Cleared Traditional

K940603 - SCIMED 8 FRENCH TRIGUIDE GUIDING CATHETER

K940603 is the FDA 510(k) clearance for SCIMED 8 FRENCH 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 69-day FDA review.

K940603 · Scimed Life Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
69d
Days
Class 2
Risk

K940603 is an FDA 510(k) clearance for the SCIMED 8 FRENCH 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 April 19, 1994 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Scimed Life Systems, Inc. devices

Submission Details

510(k) Number K940603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1994
Decision Date April 19, 1994
Days to Decision 69 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
56d faster than avg
Panel avg: 125d · This submission: 69d
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 K940603.
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
SOFTTOUCH GUIDE CATHETER
K934685 · Mallinckrodt Medical · Apr 1994
ENVOY GUIDING CATHETER
K940187 · Cordis Neurovascular, Inc. · Mar 1994
GUIDING CATHETER
K930476 · Boston Scientific Corp · Feb 1994