Home / 510(k) Clearances / K881976

510(k) K881976

CATHETER, INTRAVASCULAR by Primrose Medical, Inc. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1988
Date Received
May 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Primrose Medical, Inc.

  • K884715 — ACHELASIA BALLOON DIALATOR (September 29, 1989)
  • K884713 — COLONIC BALLOON DIALATORS (September 29, 1989)
  • K884714 — BILIARY DIALATOR (September 29, 1989)
  • K884711 — URETHRAL AND URETERAL BALLOON DILATATORS (September 29, 1989)
  • K884712 — ESOPHAGEAL AND PYLORIC BALLOON DIALATORS (September 8, 1989)
  • K884709 — ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) (September 8, 1989)
  • K883420 — LANCET, BLOOD (August 26, 1988)
  • K881977 — PRESSURE INFUSOR (July 29, 1988)
  • K881975 — SET, INTRAVASCULAR (July 29, 1988)
  • K881978 — ENTERAL FEEDING TUBES (July 13, 1988)

Other clearances for product code FOZ

  • K252398 — SURFLO Hybria Closed System Safety IV Catheter (December 17, 2025)
  • K252677 — Polyshield Safety IV Catheters (November 5, 2025)
  • K251422 — BD Saf-T-Intima™ Subcutaneous Catheter System (October 8, 2025)
  • K243403 — BD Nexiva™ Closed IV Catheter System (July 25, 2025)
  • K251155 — BD Cathena™ Safety IV Catheter (July 11, 2025)
  • K251654 — BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV (June 27, 2025)
  • K250682 — BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed (June 3, 2025)
  • K243105 — Ruby Intravascular Catheter (May 16, 2025)
  • K250292 — OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) (May 2, 2025)
  • K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual (March 27, 2025)