Cleared Traditional

K951603 - CARDIMA, INC. FORERUNNER

K951603 is an FDA 510(k) clearance for CARDIMA, manufactured by Cardima, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K951603 · Cardima, Inc. · Cardiovascular device
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Oct 1995
Decision
181d
Days
Class 2
Risk

K951603 is an FDA 510(k) clearance for the CARDIMA, INC. FORERUNNER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cardima, Inc. (Fremont, US). The FDA issued a Cleared decision on October 5, 1995 after a review of 181 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Cardima, Inc. devices

FDA 510(k) Submission Details - K951603

510(k) Number K951603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1995
Decision Date October 05, 1995
Days to Decision 181 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
56d slower than avg
Panel avg: 125d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 669
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K951603.
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5F ENVOY GUIDING CATHETER (MODIFICATION)
K954251 · Cordis Neurovascular, Inc. · Oct 1995
FASGUIDE
K951159 · Target Therapeutics · Sep 1995
SCIMED TRIGUIDE GUIDE CATHETERS
K953515 · Scimed Life Systems, Inc. · Sep 1995
MEDI-TECH PLATFORM GUIDE CATHETER
K952345 · Medi-Tech, Inc. · Aug 1995