Oscor, Inc.

FDA Regulatory Profile

Summary

Total Recalls
36 (3 Class I)
510(k) Clearances
49
Inspections
7
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0646-2022Class IIDestino Twist 14F (also branded as Guidestar 14F)December 22, 2021
Z-1329-2021Class IIAngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introducMarch 10, 2021
Z-0391-2019Class ITB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degreeSeptember 26, 2018
Z-2733-2017Class IATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 DisposabMarch 31, 2017
Z-2340-2017Class IATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable SerMarch 31, 2017
Z-0812-2017Class IIMEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 October 5, 2016
Z-0805-2017Class IIOSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the intOctober 5, 2016
Z-0790-2017Class IIOSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the intrOctober 5, 2016
Z-0813-2017Class IIMEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 IOctober 5, 2016
Z-0799-2017Class IIOSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the October 5, 2016
Z-0819-2017Class IIMEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 IsOctober 5, 2016
Z-0793-2017Class IIOSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is designed to facilitate the inOctober 5, 2016
Z-0808-2017Class IIOSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate theOctober 5, 2016
Z-0811-2017Class IIMEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 IOctober 5, 2016
Z-0810-2017Class IIOSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introOctober 5, 2016
Z-0800-2017Class IIOSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designed to facilitate the intOctober 5, 2016
Z-0795-2017Class IIOSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 Is designed to facilitate the intrOctober 5, 2016
Z-0796-2017Class IIOSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed to facilitate the introOctober 5, 2016
Z-0817-2017Class IIMEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 October 5, 2016
Z-0803-2017Class IIOSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the inOctober 5, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K210627Breezeway IIJune 3, 2021
K151951Destino ReachSeptember 22, 2015
K143463IS4/DF4 Port PlugMarch 19, 2015
K140917INTRODUCER, MODEL ADELANTE MAGNUMJuly 9, 2014
K140406DESTINO TWIST, STEERABLE GUIDING SHEATHApril 17, 2014
K130633INTRODUCER SETS, MODEL ADELANTE RADIALFebruary 13, 2014
K130843SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIREJanuary 8, 2014
K130104GUIDEWIRE, PURSUER SERIESJune 13, 2013
K122960STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINODecember 13, 2012
K122958DELIVERY SHEATH, MODEL ADELANTE BREEZEWAYDecember 13, 2012
K122084INTRODUCER SET, MODEL ADELANTE-S SERIESAugust 29, 2012
K120459STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINOJune 29, 2012
K101497DELIVERY SHEATH, MODEL ADELANTE BREEZEWAYOctober 20, 2010
K092118ANGIOGRAPHIC CATHETER, MODEL ANGIOSJanuary 13, 2010
K090114MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-SJune 4, 2009
K081986SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRENovember 14, 2008
K081052OCCLUSION BALLOON CATHETER, MODEL VENOSJune 18, 2008
K072770TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)January 22, 2008
K073100INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-SNovember 30, 2007
K070926ELECTRODE/EXTENSION CABLES, MODELS ATARJune 7, 2007