Cleared Traditional

K935597 - FASGUIDE CATHETER

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

K935597 · Target Therapeutics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 588
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