510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993816Substantially Equivalent

Baxter Percutaneous Mechanical Thrombectomy (Pmt) Device, Models Pmt0606fd and Pmt1206fd

Baxter Edwards, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993816 is the FDA 510(k) clearance record for BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD, a class II device, cleared for Baxter Edwards on under FDA product code MCW (Catheter, Peripheral, Atherectomy). FDA records list 11 510(k) clearances for Baxter Edwards, from to . As of , FDA records show no recalls naming K993816.

Clearance record

Decision date
Received
(176 days to decision)
Product code
MCW Catheter, Peripheral, Atherectomy
Regulation
21 CFR 870.4875
Device class
Class II
Review panel
Cardiovascular
Applicant
Baxter Edwards 17221 Red Hill Ave., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code MCW

Trailing 12 months
1 clearance under product code MCW in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MCW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260