Home / 510(k) Clearances / K920676

510(k) K920676

RMI SOFCLAMP by Research Medical, Inc. — Product Code DSS

K920676 is an FDA 510(k) premarket notification submitted by Research Medical, Inc. for the device "RMI SOFCLAMP". The FDA issued a decision of Substantially Equivalent on April 15, 1992. The device falls under product code DSS (Clip, Vascular), a Class II device regulated under 21 CFR 870.3250. Research Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1992
Date Received
February 14, 1992
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 Research Medical, Inc.

  • K970739 — RMI HEMOCONCENTRATOR PREFERENCE PACK (July 8, 1997)
  • K964833 — RMI DUAL FLUID IRRIGATING SYRINGE (February 19, 1997)
  • K961927 — RMI HEMOCONCENTRACTOR TUBING SET (August 13, 1996)
  • K960098 — RMI INTERNAL MAMMARY ARTERY CANNULA (March 26, 1996)
  • K951344 — RMI HEMOCONCENTRATOR (August 15, 1995)
  • K922083 — RMI SURGICCAL SITE VISUALIZATION WAND (January 29, 1993)
  • K920936 — RMI EXTERNAL CORONARY ARTERY OCCLUDER (December 18, 1992)
  • K915869 — RMI NORMOCLUDER CORONARY ARTERY OCCLUDER (December 8, 1992)
  • K910221 — RMI VASCULAR TOURNIQUET KIT (May 16, 1991)
  • K901231 — RMI CARDIOPLEGIA DELIVERY KITS (June 8, 1990)

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)
  • K914523 — CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL (January 10, 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