Cleared Traditional

K951159 - FASGUIDE

K951159 is the FDA 510(k) clearance for FASGUIDE by Target Therapeutics. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K951159 · Target Therapeutics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
195d
Days
Class 2
Risk

K951159 is an FDA 510(k) clearance for the FASGUIDE. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Target Therapeutics (Freemont, US). The FDA issued a Cleared decision on September 25, 1995 after a review of 195 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 Target Therapeutics devices

Submission Details

510(k) Number K951159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1995
Decision Date September 25, 1995
Days to Decision 195 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
70d slower than avg
Panel avg: 125d · This submission: 195d
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 K951159.
SCIMED ANGIOGRAPHIC KITS
K953265 · Scimed Life Systems, Inc. · Jan 1996
ACS TOURGIDE GUIDING CATHETER
K953987 · Advanced Cardiovascular Systems, Inc. · Dec 1995
5F ENVOY GUIDING CATHETER (MODIFICATION)
K954251 · Cordis Neurovascular, Inc. · Oct 1995
SCIMED TRIGUIDE GUIDE CATHETERS
K953515 · Scimed Life Systems, Inc. · Sep 1995
MEDI-TECH PLATFORM GUIDE CATHETER
K952345 · Medi-Tech, Inc. · Aug 1995
ACS POWERBASE GUILDING CATHETER
K952205 · Advanced Cardiovascular Systems, Inc. · Aug 1995