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510(k) K914523

CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL by Catheter Research C/O Burditt, Bowles & Radzius — Product Code DSS

K914523 is an FDA 510(k) premarket notification submitted by Catheter Research C/O Burditt, Bowles & Radzius for the device "CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL". The FDA issued a decision of Substantially Equivalent on January 10, 1992. The device falls under product code DSS (Clip, Vascular), a Class II device regulated under 21 CFR 870.3250. Catheter Research C/O Burditt, Bowles & Radzius has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1992
Date Received
October 10, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Vascular
Device Class
Class II
Regulation Number
870.3250
Review Panel
CV
Submission Type

Other clearances by Catheter Research C/O Burditt, Bowles & Radzius

  • K924227 — CRI CYNOSAR CATHETER (June 29, 1993)
  • K924125 — CRI ELECTRONIC CONTROL SYSTEM (May 26, 1993)
  • K904785 — CRI CYNOSAR CATHETER (March 6, 1991)
  • K904787 — CRI STEERABLE CATHETER CONTROL SYSTEM (December 17, 1990)
  • K900320 — CRI CYNOSAR CATHETER (September 14, 1990)
  • K884337 — MICRO-GUIDE SYSTEM (January 5, 1989)
  • K870700 — MICRO-GUIDE (December 3, 1987)

Other clearances for product code DSS

  • K983744 — MCAS (MODULAR CLIP APPLIER SYSTEM) (January 21, 1999)
  • K961333 — HEARTPORT MULTIFIRE CLIP APPLIER (November 15, 1996)
  • K920104 — IDENTI LOOPS DEGANIA SILICONE (April 20, 1992)
  • K920676 — RMI SOFCLAMP (April 15, 1992)
  • K901303 — HORIZON SURGICAL LIGATING AND MARKING CLIP (June 5, 1990)
  • K883909 — SURGICAL SPRING CLIPS (December 27, 1988)
  • K771021 — AUTO-CLIP (June 14, 1977)

FDA data resources