Cleared Traditional

K921649 - RETRIEVER 10

K921649 is the FDA 510(k) clearance for RETRIEVER 10 by Target Therapeutics. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K921649 · Target Therapeutics · Cardiovascular device
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Mar 1993
Decision
339d
Days
Class 2
Risk

K921649 is an FDA 510(k) clearance for the RETRIEVER 10. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Target Therapeutics (Freemont, US). The FDA issued a Cleared decision on March 11, 1993 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Target Therapeutics devices

Submission Details

510(k) Number K921649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1992
Decision Date March 11, 1993
Days to Decision 339 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
214d slower than avg
Panel avg: 125d · This submission: 339d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 292
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K921649.
BALT GUIDING CATHETER
K925632 · Target Therapeutics · Jun 1993
CORDIS 7 FRENCH THRULUMEN CATHETER
K922891 · Cordis Corp. · Jun 1993
NYLEX CATHETERS
K930479 · Cordis Corp. · Apr 1993
COBE SAMPLING SITE
K922484 · Cobe Cardiovascular, Inc. · Dec 1992
USCI LINX EZ GUIDE WIRE EXTEN. W/ PRO/PEL COATING
K922105 · C.R. Bard, Inc. · Nov 1992
SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA
K923480 · Scimed Life Systems, Inc. · Oct 1992