Cleared Traditional

HEARTPORT ENDOAORTIC CLAMP CATHETER (K974175) - FDA 510(k) Clearance

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

K974175 · Heartport, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
40d
Days
Class 2
Risk

K974175 is an FDA 510(k) clearance for the HEARTPORT ENDOAORTIC CLAMP CATHETER. Classified as Device, Biopsy, Endomyocardial (product code DWZ), Class II - Special Controls.

Submitted by Heartport, Inc. (Redwood City, US). The FDA issued a Cleared decision on December 16, 1997 after a review of 40 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Heartport, Inc. devices

Submission Details

510(k) Number K974175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1997
Decision Date December 16, 1997
Days to Decision 40 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
85d faster than avg
Panel avg: 125d · This submission: 40d
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 K974175.
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CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE
K932788 · Cordis Corp. · Sep 1993
CORDIS BIPAL 7 BIOPSY FORCEPS
K920289 · Cordis Corp. · Mar 1992