Cleared Traditional

K933235 - CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY F...

K933235 is an FDA 510(k) clearance for CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY F..., manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DWZ cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K933235 · Cordis Corp. · Cardiovascular device
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Jan 1994
Decision
232d
Days
Class 2
Risk

K933235 is an FDA 510(k) clearance for the CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF. Classified as Device, Biopsy, Endomyocardial (product code DWZ), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on January 6, 1994 after a review of 232 days - an extended review cycle.

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 Cordis Corp. devices

FDA 510(k) Submission Details - K933235

510(k) Number K933235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1993
Decision Date January 06, 1994
Days to Decision 232 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 125d · This submission: 232d
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 13
Devices cleared under the same product code (DWZ) and FDA review panel - the closest regulatory comparables to K933235.
MODIFICATION TO T-REX BIOPSY FORCEPS
K000409 · Boston Scientific Corp · Feb 2000
T-REX BIOPSY FORCEPS
K973818 · Boston Scientific Corp · Dec 1997
HEARTPORT ENDOAORTIC CLAMP CATHETER
K974175 · Heartport, Inc. · Dec 1997
CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE
K932788 · Cordis Corp. · Sep 1993
BIOPSY FORCEPS
K921401 · Annex Medical, Inc. · Oct 1992
CORDIS BIPAL 7 BIOPSY FORCEPS
K920289 · Cordis Corp. · Mar 1992