Cleared Traditional

K950094 - SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CAT...

K950094 is the FDA 510(k) clearance for SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CAT... by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K950094 · Scimed Life Systems, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
52d
Days
Class 2
Risk

K950094 is an FDA 510(k) clearance for the SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Maple Grove, US). The FDA issued a Cleared decision on March 3, 1995 after a review of 52 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 K950094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1995
Decision Date March 03, 1995
Days to Decision 52 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
73d faster than avg
Panel avg: 125d · This submission: 52d
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 K950094.
ACS POWERBASE GUILDING CATHETER
K952205 · Advanced Cardiovascular Systems, Inc. · Aug 1995
CORDIS BRITE TIP, ENVOY GUIDING CATHETER
K952185 · Cordis Corp. · Aug 1995
SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS
K946204 · Scimed Life Systems, Inc. · Mar 1995
CANDELA SHEATH SETS
K950634 · Candela Laser Corp. · Mar 1995
CANDEKA DUKATIR SETS
K950635 · Candela Laser Corp. · Mar 1995
5F ENVOY(TM) GUIDING CATHETER
K945705 · Cordis Neurovascular, Inc. · Feb 1995