Cleared Traditional

K901502 - AMPLATZ GOOSE-NECK SNARE

K901502 is an FDA 510(k) clearance for AMPLATZ GOOSE-NECK SNARE, manufactured by Microvena Corp.. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K901502 · Microvena Corp. · Cardiovascular device
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Dec 1990
Decision
249d
Days
Class 2
Risk

K901502 is an FDA 510(k) clearance for the AMPLATZ GOOSE-NECK SNARE. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Microvena Corp. (Findley, US). The FDA issued a Cleared decision on December 3, 1990 after a review of 249 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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. Standard predicate reliance. 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 Microvena Corp. devices

FDA 510(k) Submission Details - K901502

510(k) Number K901502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1990
Decision Date December 03, 1990
Days to Decision 249 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 125d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXE Device Classification - Class 2, Special Controls

Product Code DXE Catheter, Embolectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - DXE Catheter, Embolectomy

All 44
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K901502.
ARTERIAL EMBOLECTOMY
K935405 · J-Lloyd Medical, Inc. · Jul 1994
WELTER SNARE RETRIEVER
K920823 · Cook, Inc. · Mar 1993
INTIMAX THROMBECTOMY CATHETER
K910372 · Applied Vascular Devices, Inc. · Apr 1991
ARTERIAL EMBOLECTOMY CATHETER
K901627 · Applied Vascular Devices, Inc. · Oct 1990
ARTERIAL EMBOLECTOMY CATHETER
K900311 · Impra, Inc. · Jul 1990
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
K901625 · Baxter Healthcare Corp · Jul 1990