Cleared Traditional

K993816 - BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD

K993816 is an FDA 510(k) clearance for BAXTER PERCUTANEOUS MECHANICAL THROMBEC..., manufactured by Baxter Edwards. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K993816 · Baxter Edwards · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
176d
Days
Class 2
Risk

K993816 is an FDA 510(k) clearance for the BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AN.... Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Baxter Edwards (Irvine, US). The FDA issued a Cleared decision on May 4, 2000 after a review of 176 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - 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 Baxter Edwards devices

FDA 510(k) Submission Details - K993816

510(k) Number K993816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1999
Decision Date May 04, 2000
Days to Decision 176 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
51d slower than avg
Panel avg: 125d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MCW Device Classification - Class 2, Special Controls

Product Code MCW Catheter, Peripheral, Atherectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
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 - MCW Catheter, Peripheral, Atherectomy

All 102
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K993816.
THROMCAT THROMBECTOMY CATHETER SYSTEM
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DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
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THROMCAT THROMBECTOMY CATHETER SYSTEM
K060016 · Kensey Nash Corp. · Apr 2006
POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002
K993564 · Possis Medical, Inc. · Apr 2000
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65
K990829 · Arrow Intl., Inc. · May 1999
OASIS THROMBECTOMY CATHETER SYSTEM
K982363 · Boston Scientific Corp · Feb 1999