Cleared Traditional

K941137 - SCIMED TRIGUIDE GUIDING CATHETER

K941137 is the FDA 510(k) clearance for SCIMED TRIGUIDE GUIDING CATHETER by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K941137 · Scimed Life Systems, Inc. · Cardiovascular device
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Jun 1994
Decision
104d
Days
Class 2
Risk

K941137 is an FDA 510(k) clearance for the SCIMED TRIGUIDE GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Plymouth, US). The FDA issued a Cleared decision on June 22, 1994 after a review of 104 days - within the typical 510(k) review window.

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 Scimed Life Systems, Inc. devices

Submission Details

510(k) Number K941137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1994
Decision Date June 22, 1994
Days to Decision 104 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
21d faster than avg
Panel avg: 125d · This submission: 104d
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 581
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K941137.
FASGUIDE CATHETER
K935597 · Target Therapeutics · 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
SCHNEIDER GUIDEZILLA SOFTIP GUIDING CATHETER
K935292 · Boston Scientific Scimed, Inc. · Jun 1994
SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX GUID CATH
K940545 · Scimed Life Systems, Inc. · May 1994
ACS POWERBASE(TM) CORONARY GUIDING CATHETER
K940559 · Advanced Cardiovascular Systems, Inc. · May 1994