Cleared Traditional

K934581 - SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS

K934581 is an FDA 510(k) clearance for SCIMED 5, 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 189-day FDA review.

K934581 · Scimed Life Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
189d
Days
Class 2
Risk

K934581 is an FDA 510(k) clearance for the SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Plymouth, US). The FDA issued a Cleared decision on March 31, 1994 after a review of 189 days - an extended review 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: 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

FDA 510(k) Submission Details - K934581

510(k) Number K934581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1993
Decision Date March 31, 1994
Days to Decision 189 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
64d slower than avg
Panel avg: 125d · This submission: 189d
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 K934581.
SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION
K934541 · Scimed Life Systems, Inc. · May 1994
WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
K935403 · J-Lloyd Medical, Inc. · May 1994
ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD
K935402 · J-Lloyd Medical, Inc. · Apr 1994
DIAGNOSTIC INTRAVASCULAR CATHETER
K925813 · Target Therapeutics · Mar 1994
SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH
K935654 · Scimed Life Systems, Inc. · Feb 1994
CARAPACE ANGIOGRAPHY TRAYS
K931629 · Carapace, Inc. · Dec 1993