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510(k) K043581

DUAL LUMEN CATHETER by Acmi Corporation — Product Code EYB

K043581 is an FDA 510(k) premarket notification submitted by Acmi Corporation for the device "DUAL LUMEN CATHETER". The FDA issued a decision of Substantially Equivalent on March 3, 2005. The device falls under product code EYB (Catheter, Ureteral, Gastro-Urology), a Class II device regulated under 21 CFR 876.5130. Acmi Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2005
Date Received
December 28, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ureteral, Gastro-Urology
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Acmi Corporation

  • K061975 — PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK (August 10, 2006)
  • K060752 — ACMI DUR-HL LASER SYSTEMS (May 25, 2006)
  • K060269 — ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM (March 31, 2006)
  • K051593 — UROPASS URETERAL ACCESS SHEATH, MODEL 61224 (September 2, 2005)
  • K052044 — ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL (August 16, 2005)
  • K042069 — INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM (November 1, 2004)
  • K042225 — ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 (September 10, 2004)
  • K031758 — ACMI M4 TELESCOPES (September 2, 2003)
  • K030960 — ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE (July 16, 2003)
  • K030935 — BERKELEY V-10 VACUUM CURETTAGE SYSTEM (June 23, 2003)

Other clearances for product code EYB

  • K192183 — RocaTub Ureteral Catheter (April 23, 2020)
  • K191187 — Dornier MINNOW Ureteral Catheter (September 18, 2019)
  • K183323 — UPJ Occlusion Balloon Catheter (August 5, 2019)
  • K182695 — Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter (June 17, 2019)
  • K182122 — Ureteric Catheters (October 4, 2018)
  • K180182 — Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Cathet (September 14, 2018)
  • K171043 — Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric C (December 21, 2017)
  • K133750 — OCCLUDER OCCLUSION BALLOON CATHETER (January 8, 2014)
  • K092250 — MEDLINE RED RUBBER URETHRAL CATHETER (January 21, 2010)
  • K083788 — ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR (March 3, 2009)

FDA data resources