Cleared Traditional

RMI SOFCLAMP

K920676 · Research Medical, Inc. · Cardiovascular
Apr 1992
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K920676 is an FDA 510(k) clearance for the RMI SOFCLAMP, a Clip, Vascular (Class II — Special Controls, product code DSS), submitted by Research Medical, Inc. (Midvale, US). The FDA issued a Cleared decision on April 15, 1992, 61 days after receiving the submission on February 14, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3250.

Submission Details

510(k) Number K920676 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 1992
Decision Date April 15, 1992
Days to Decision 61 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DSS — Clip, Vascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3250

Similar Devices — DSS Clip, Vascular

All 7
MCAS (MODULAR CLIP APPLIER SYSTEM)
K983744 · Applied Medical Resources · Jan 1999
HEARTPORT MULTIFIRE CLIP APPLIER
K961333 · Heartport, Inc. · Nov 1996
IDENTI LOOPS DEGANIA SILICONE
K920104 · Puritas Health Care, Inc. · Apr 1992
CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL
K914523 · Catheter Research C/O Burditt, Bowles & Radzius · Jan 1992
HORIZON SURGICAL LIGATING AND MARKING CLIP
K901303 · Horizon Surgical, Inc. · Jun 1990
SURGICAL SPRING CLIPS
K883909 · Applied Vascular Devices, Inc. · Dec 1988