510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190634Substantially Equivalent

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System

Cardiovascular Systems Incorporated, St.Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190634 is the FDA 510(k) clearance record for Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, a class II device, cleared for Cardiovascular Systems, Inc. on under FDA product code MCW (Catheter, Peripheral, Atherectomy). FDA records list 28 510(k) clearances for CARDIOVASCULAR SYSTEMS INCORPORATED, from to . As of , FDA records show 2 recalls naming K190634.

Clearance record

Decision date
Received
(112 days to decision)
Product code
MCW Catheter, Peripheral, Atherectomy
Regulation
21 CFR 870.4875
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardiovascular Systems, Inc. 1225 Old Hwy. 8 NW, St.Paul MN
510(k) summary
Summary PDF
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