Cleared Traditional

K931629 - CARAPACE ANGIOGRAPHY TRAYS

K931629 is an FDA 510(k) clearance for CARAPACE ANGIOGRAPHY TRAYS, manufactured by Carapace, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K931629 · Carapace, Inc. · Cardiovascular device
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Dec 1993
Decision
248d
Days
Class 2
Risk

K931629 is an FDA 510(k) clearance for the CARAPACE ANGIOGRAPHY TRAYS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Carapace, Inc. (Broken Arrow, US). The FDA issued a Cleared decision on December 6, 1993 after a review of 248 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 Carapace, Inc. devices

FDA 510(k) Submission Details - K931629

510(k) Number K931629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1993
Decision Date December 06, 1993
Days to Decision 248 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 125d · This submission: 248d
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 325
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K931629.
SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS
K934581 · Scimed Life Systems, Inc. · Mar 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
DYE MANAGEMENT SYSTEM
K933700 · Abbott Laboratories · Nov 1993
SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
K931479 · Mallinckrodt Medical · Oct 1993
CARDIAC CATH OR ANGIOGRAPHIC TRAYS
K932218 · Associated Medical Products Co. · Aug 1993