Cleared Traditional

K952872 - SSCIMED CORONARY GUIDE WIRE/INFUSION CA...

K952872 is the FDA 510(k) clearance for SSCIMED CORONARY GUIDE WIRE/INFUSION CA... by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K952872 · Scimed Life Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
78d
Days
Class 2
Risk

K952872 is an FDA 510(k) clearance for the SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Maple Grove, US). The FDA issued a Cleared decision on July 27, 1995 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 K952872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1995
Decision Date July 27, 1995
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 127
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K952872.
MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE
K954020 · Micro Therapeutics, Inc. · Jan 1996
TRANSIT INFUSION CATHETER WITH SIDEHOLES
K954949 · Cordis Neurovascular, Inc. · Dec 1995
TRANSIT INFUSION CATHETER
K952874 · Cordis Neurovascular, Inc. · Aug 1995
EVOLUTION(TM) MICROCATHETER
K945666 · Boston Scientific Corp · Jun 1995
SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER
K945593 · Scimed Life Systems, Inc. · Jan 1995
SCIMED(R) VENTURE(TM) INFUSION CATHETER
K931335 · Scimed Life Systems, Inc. · Jul 1994