Cleared Traditional

K950813 - MOLLRING CUTTER

K950813 is an FDA 510(k) clearance for MOLLRING CUTTER, manufactured by Cardio Vascular Concepts, Inc.. The device is a Class 2 Cardiovascular device with product code DWX cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K950813 · Cardio Vascular Concepts, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
153d
Days
Class 2
Risk

K950813 is an FDA 510(k) clearance for the MOLLRING CUTTER. Classified as Stripper, Artery, Intraluminal (product code DWX), Class II - Special Controls.

Submitted by Cardio Vascular Concepts, Inc. (Portola Valley, US). The FDA issued a Cleared decision on July 25, 1995 after a review of 153 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardio Vascular Concepts, Inc. devices

FDA 510(k) Submission Details - K950813

510(k) Number K950813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1995
Decision Date July 25, 1995
Days to Decision 153 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 125d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWX Device Classification - Class 2, Special Controls

Product Code DWX Stripper, Artery, Intraluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWX Stripper, Artery, Intraluminal

All 8
Devices cleared under the same product code (DWX) and FDA review panel - the closest regulatory comparables to K950813.
MOLLRING MULTITASC
K121415 · LeMaitre Vascular, Inc. · Sep 2012
EXTERNAL VEIN STRIPPER
K933498 · Applied Medical Resources · Mar 1994
MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE
K911099 · Pilling Co. · Jun 1991
TRANSLUMINAL ENDARTERECTOMY DEVICE
K904944 · Baxter Healthcare Corp · Dec 1990
OLYMPUS VALVULOTOME W/DETACHABLE TIP
K895878 · Olympus Corp. · Jan 1990
OLYMPUS VALVULOTOME W/FIXED TIP
K894496 · Olympus Corp. · Oct 1989