Cleared Traditional

K951447 - DYNABITE CARDIOVASCULAR BIOPSY FORCEPS

K951447 is an FDA 510(k) clearance for DYNABITE CARDIOVASCULAR BIOPSY FORCEPS, manufactured by Portlyn Corp.. The device is a Class 2 Cardiovascular device with product code DWZ cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K951447 · Portlyn Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
120d
Days
Class 2
Risk

K951447 is an FDA 510(k) clearance for the DYNABITE CARDIOVASCULAR BIOPSY FORCEPS. Classified as Device, Biopsy, Endomyocardial (product code DWZ), Class II - Special Controls.

Submitted by Portlyn Corp. (Moultonboro, US). The FDA issued a Cleared decision on July 27, 1995 after a review of 120 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 Portlyn Corp. devices

FDA 510(k) Submission Details - K951447

510(k) Number K951447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1995
Decision Date July 27, 1995
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
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 11
Devices cleared under the same product code (DWZ) and FDA review panel - the closest regulatory comparables to K951447.
Biopsy Forceps
K252722 · Fehling Instruments GmbH · Sep 2025
MODIFICATION TO T-REX BIOPSY FORCEPS
K000409 · Boston Scientific Corp · Feb 2000
T-REX BIOPSY FORCEPS
K973818 · Boston Scientific Corp · Dec 1997
CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF
K933235 · Cordis Corp. · Jan 1994
CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE
K932788 · Cordis Corp. · Sep 1993
CORDIS BIPAL 7 BIOPSY FORCEPS
K920289 · Cordis Corp. · Mar 1992