Cleared Traditional

K935597 - FASGUIDE CATHETER

K935597 is an FDA 510(k) clearance for FASGUIDE CATHETER, manufactured by Target Therapeutics. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K935597 · Target Therapeutics · Cardiovascular device
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Oct 1994
Decision
333d
Days
Class 2
Risk

K935597 is an FDA 510(k) clearance for the FASGUIDE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Target Therapeutics (Freemont, US). The FDA issued a Cleared decision on October 18, 1994 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Target Therapeutics devices

FDA 510(k) Submission Details - K935597

510(k) Number K935597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1993
Decision Date October 18, 1994
Days to Decision 333 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
208d slower than avg
Panel avg: 125d · This submission: 333d
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 792
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K935597.
5F ENVOY(TM) GUIDING CATHETER
K945705 · Cordis Neurovascular, Inc. · Feb 1995
SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETER
K943622 · Boston Scientific Scimed, Inc. · Nov 1994
SCIMED TRIGUIDE GUIDE CATHETER
K944537 · Scimed Life Systems, Inc. · Oct 1994
SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER
K943777 · Scimed Life Systems, Inc. · Oct 1994
7 FRENCH LARGE LUMEN TRIGUIDE-PLUS
K943783 · Scimed Life Systems, Inc. · Oct 1994
SCIMED TRIGUIDE GUIDING CATHETER
K941137 · Scimed Life Systems, Inc. · Jun 1994