510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K982657Substantially Equivalent

Amplatz Thrombectomy Device Models Atd 601, Atd 602, Atd 801, Atd 802, Foot Pedal Assembly Model Ak 100

Microvena Corp., White Bear Lake MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982657 is the FDA 510(k) clearance record for AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100, a class II device, cleared for Microvena Corp. on under FDA product code MCW (Catheter, Peripheral, Atherectomy). FDA records list 18 510(k) clearances for Microvena Corp., from to . As of , FDA records show no recalls naming K982657.

Clearance record

Decision date
Received
(111 days to decision)
Product code
MCW Catheter, Peripheral, Atherectomy
Regulation
21 CFR 870.4875
Device class
Class II
Review panel
Cardiovascular
Applicant
Microvena Corp. 1861 Buerkle Rd., White Bear Lake MN
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