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Stealth PRD-SC30-MICRO

by Cardiovascular Systems, Inc.

Stealth PRD-SC30-MICRO (7-10059-01) is a Class II device made by Cardiovascular Systems, Inc., listed in FDA GUDID since 10 Sep 2019 (UDI-DI 10850000491264), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10850000491264 UDI-DI Date10 Sep 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Stealth
Generic name
Mechanical atherectomy system catheter, peripheral
Model / Ref / Catalog
PRD-SC30-MICRO, 7-10059-01
Primary DI / UDI-DI
10850000491264
FDA product code
MCW
GMDN term
Mechanical atherectomy system catheter, peripheral
Device class
Class II
Regulation number
870.4875
GUDID distribution status
In Commercial Distribution

Related devices

Category: Mechanical atherectomy system catheter, peripheral

Similar devices

Other devices filed under FDA product code MCW (Catheter, Peripheral, Atherectomy).

Other devices from Cardiovascular Systems, Inc.

See all devices from Cardiovascular Systems, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)