Cleared Traditional

K921649 - RETRIEVER 10

K921649 is an FDA 510(k) clearance for RETRIEVER 10, manufactured by Target Therapeutics. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K921649

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.

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 408
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K921649.
SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER
K926003 · Schneider Intl., Ltd. · Jun 1993
CVIS LONGVIEW
K930311 · Cardiovascular Imaging Systems, Inc. · Jun 1993
NYLEX CATHETERS
K930479 · Cordis Corp. · Apr 1993
MORSE(R) ANGIOGRAPHIC CATHETERS
K922552 · North American Instrument Corp. · Mar 1993
ANGIOGRAPHIC CATHETER -- MODIFICATION
K922101 · Interventional Therapeutics Corp. · Feb 1993
COBE SAMPLING SITE
K922484 · Cobe Cardiovascular, Inc. · Dec 1992