Cleared Traditional

THE AMPLANTZ GOOSE NECK MICROSNARE (K970668) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970668 · Microvena Corp. · Cardiovascular device
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Jun 1998
Decision
471d
Days
Class 2
Risk

K970668 is an FDA 510(k) clearance for the THE AMPLANTZ GOOSE NECK MICROSNARE. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Microvena Corp. (White Bear Lake, US). The FDA issued a Cleared decision on June 10, 1998 after a review of 471 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Microvena Corp. devices

Submission Details

510(k) Number K970668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1997
Decision Date June 10, 1998
Days to Decision 471 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
346d slower than avg
Panel avg: 125d · This submission: 471d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 306
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K970668.
ENVY GUIDING CATHETER
K990726 · Cook, Inc. · Apr 1999
ENVOY AND VISTA BRITE TIP
K982632 · Cordis Corp. · Aug 1998
6F ENVOY GUIDING CATHETER
K982770 · Cordis Corp. · Aug 1998
VISTA BRITE TIP GUIDING CATHETERS
K972978 · Cordis Corp. · Oct 1997
VISTA BRITE TIP CATHETERS
K971572 · Cordis Corp. · Jul 1997
VISTA BRITE TIP CATHETERS
K963962 · Cordis Corp. · May 1997