Cleared Traditional

K964210 - RETRIEVER II

K964210 is the FDA 510(k) clearance for RETRIEVER II by Target Therapeutics. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 374-day FDA review.

K964210 · Target Therapeutics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
374d
Days
Class 2
Risk

K964210 is an FDA 510(k) clearance for the RETRIEVER II. 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 October 31, 1997 after a review of 374 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 K964210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1996
Decision Date October 31, 1997
Days to Decision 374 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
249d slower than avg
Panel avg: 125d · This submission: 374d
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 291
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K964210.
SITESEER ANGIOGRAPHIC CATHETER
K980575 · C.R. Bard, Inc. · May 1998
SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
K974559 · Scimed Life Systems, Inc. · Feb 1998
TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
K973401 · Cordis Corp. · Nov 1997
MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS
K965112 · Medline Industries, Inc. · Oct 1997
5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER
K970854 · Cordis Corp. · Sep 1997
MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS
K970207 · Boston Scientific Corp · Jul 1997