Cleared Traditional

K001694 - GUIDANT RETRIEVER DEVICE

K001694 is an FDA 510(k) clearance for GUIDANT RETRIEVER DEVICE, manufactured by Guidant Cardiac and Vascular Surgery. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K001694 · Guidant Cardiac and Vascular Surgery · Cardiovascular device
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May 2001
Decision
347d
Days
Class 2
Risk

K001694 is an FDA 510(k) clearance for the GUIDANT RETRIEVER DEVICE. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Guidant Cardiac and Vascular Surgery (Menlo Park, US). The FDA issued a Cleared decision on May 15, 2001 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Guidant Cardiac and Vascular Surgery devices

FDA 510(k) Submission Details - K001694

510(k) Number K001694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2000
Decision Date May 15, 2001
Days to Decision 347 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 125d · This submission: 347d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 668
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K001694.
AVIATOR PERIPHERAL DILATATION CATHETER
K010831 · Guidant Corp. · Jun 2001
CONCENTRIC RETRIEVER, MODEL 90030
K003410 · Concentric Medical, Inc. · May 2001
CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)
K003880 · Concentric Medical, Inc. · May 2001
NUMED HIGH PRESSURE PTA CATHETERS
K010880 · NuMED, Inc. · Apr 2001
ILT DEFLECTING CATHETER, MODEL C114ND1
K010531 · Intra Luminal Therapeutics, Inc. · Apr 2001
GUIDER SOFTIP GUIDING CATHETER XF 5F
K010853 · Boston Scientific, Target · Apr 2001