Cleared Traditional

K932542 - SCIMED 6F ANGIOGRAPHIC CATHETER

K932542 is an FDA 510(k) clearance for SCIMED 6F ANGIOGRAPHIC CATHETER, manufactured by Scimed Life Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K932542 · Scimed Life Systems, Inc. · Cardiovascular device
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Aug 1993
Decision
77d
Days
Class 2
Risk

K932542 is an FDA 510(k) clearance for the SCIMED 6F ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Maple Grove, US). The FDA issued a Cleared decision on August 11, 1993 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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

FDA 510(k) Submission Details - K932542

510(k) Number K932542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1993
Decision Date August 11, 1993
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 406
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K932542.
CARDIAC CATH OR ANGIOGRAPHIC TRAYS
K932218 · Associated Medical Products Co. · Aug 1993
SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING
K932420 · Scimed Life Systems, Inc. · Aug 1993
ANGIOGRAPHIC CATHETER
K926243 · Target Therapeutics · Aug 1993
USCI ANGIOGRAPHIC CATHETER
K932092 · C.R. Bard, Inc. · Jul 1993
CVIS INSIGHT IMAGING GUIDE CATHETER
K930232 · Cardiovascular Imaging Systems, Inc. · Jul 1993
CVIS INSIGHT IMAGING CATHETER
K924922 · Cardiovascular Imaging Systems, Inc. · Jun 1993