Cleared Traditional

VASCULAR BIOPSY FORCEPS (K910840) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910840 · Vascular Products, Inc. · Cardiovascular device
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Jul 1991
Decision
138d
Days
Class 2
Risk

K910840 is an FDA 510(k) clearance for the VASCULAR BIOPSY FORCEPS. Classified as Device, Biopsy, Endomyocardial (product code DWZ), Class II - Special Controls.

Submitted by Vascular Products, Inc. (Tarpon Springs, US). The FDA issued a Cleared decision on July 15, 1991 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4075 - 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 Vascular Products, Inc. devices

Submission Details

510(k) Number K910840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1991
Decision Date July 15, 1991
Days to Decision 138 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 125d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWZ Device, Biopsy, Endomyocardial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4075
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 - DWZ Device, Biopsy, Endomyocardial

All 9
Devices cleared under the same product code (DWZ) and FDA review panel - the closest regulatory comparables to K910840.
CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE
K932788 · Cordis Corp. · Sep 1993
CORDIS BIPAL 7 BIOPSY FORCEPS
K920289 · Cordis Corp. · Mar 1992
CORDIS BIPAL BIOPSY FORCEPS
K914567 · Cordis Corp. · Dec 1991
FLEXIBLE MYOCARDIAL BIOPSY FORCEPS
K883723 · Cook, Inc. · Dec 1988
CORDIS BIOPSY FORCEPS
K810849 · Cordis Corp. · Apr 1981