510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K991093Substantially Equivalent

Msd Embolectomy Basket

Metamorphic Surgical Devices, LLC, Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991093 is the FDA 510(k) clearance record for MSD EMBOLECTOMY BASKET, a class II device, cleared for Metamorphic Surgical Devices, LLC on under FDA product code QEW (Peripheral Mechanical Thrombectomy With Aspiration). FDA's definition for product code QEW reads: "To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration". FDA records list one 510(k) clearance for Metamorphic Surgical Devices, LLC. As of , FDA records show no recalls naming K991093.

Clearance record

Decision date
Received
(630 days to decision)
Product code
QEW Peripheral Mechanical Thrombectomy With Aspiration
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Metamorphic Surgical Devices, LLC 660 William Pitt Way, Pittsburgh PA
510(k) summary
Summary
Third party review
No

Clearances, product code QEW

Trailing 12 months
11 clearances under product code QEW in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QEW, trailing twelve months
MonthClearances
November 20251
December 20251
January 20262
February 20262
March 20260
April 20261
May 20260
June 20260
July 20260
August 20262
September 20262
October 20260