Cleared Traditional

K961333 - HEARTPORT MULTIFIRE CLIP APPLIER

K961333 is an FDA 510(k) clearance for HEARTPORT MULTIFIRE CLIP APPLIER, manufactured by Heartport, Inc.. The device is a Class 2 Cardiovascular device with product code DSS cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K961333 · Heartport, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Nov 1996
Decision
221d
Days
Class 2
Risk

K961333 is an FDA 510(k) clearance for the HEARTPORT MULTIFIRE CLIP APPLIER. Classified as Clip, Vascular (product code DSS), Class II - Special Controls.

Submitted by Heartport, Inc. (Redwood City, US). The FDA issued a Cleared decision on November 15, 1996 after a review of 221 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3250 - 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 Heartport, Inc. devices

FDA 510(k) Submission Details - K961333

510(k) Number K961333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1996
Decision Date November 15, 1996
Days to Decision 221 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
96d slower than avg
Panel avg: 125d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSS Device Classification - Class 2, Special Controls

Product Code DSS Clip, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3250
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 - DSS Clip, Vascular

Devices cleared under the same product code (DSS) and FDA review panel - the closest regulatory comparables to K961333.
MCAS (MODULAR CLIP APPLIER SYSTEM)
K983744 · Applied Medical Resources · Jan 1999
IDENTI LOOPS DEGANIA SILICONE
K920104 · Puritas Health Care, Inc. · Apr 1992
RMI SOFCLAMP
K920676 · Research Medical, Inc. · Apr 1992
SURGICAL SPRING CLIPS
K883909 · Applied Vascular Devices, Inc. · Dec 1988
AUTO-CLIP
K771021 · Axiom Medical, Inc. · Jun 1977