Cleared Traditional

K910840 - VASCULAR BIOPSY FORCEPS

K910840 is an FDA 510(k) clearance for VASCULAR BIOPSY FORCEPS, manufactured by Vascular Products, Inc.. The device is a Class 2 Cardiovascular device with product code DWZ cleared through the Traditional 510(k) pathway after a 138-day FDA review.

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

FDA 510(k) Submission Details - K910840

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.

DWZ Device Classification - Class 2, Special Controls

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 17
Devices cleared under the same product code (DWZ) and FDA review panel - the closest regulatory comparables to K910840.
BIOPSY FORCEPS
K921401 · Annex Medical, Inc. · Oct 1992
CORDIS BIPAL 7 BIOPSY FORCEPS
K920289 · Cordis Corp. · Mar 1992
CORDIS BIPAL BIOPSY FORCEPS
K914567 · Cordis Corp. · Dec 1991
BIOPSY FORCEPS
K895098 · Annex Medical, Inc. · Oct 1989
REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES
K890453 · Dlp, Inc. · Mar 1989
FLEXIBLE MYOCARDIAL BIOPSY FORCEPS
K883723 · Cook, Inc. · Dec 1988