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Zuma® ZS8FL40

by Medtronic, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

10 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00613994788726 UDI-DI Date22 Apr 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

10 recalls · FDA

  • 10 recalls, same reason

    • Terminated Z-1049-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1052-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1053-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1046-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1047-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1051-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1045-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1050-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1044-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1048-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006

    Potential for non-sterility due to loss of package integrity

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Zuma®
Generic Name
Vascular guide-catheter, single-use
Model / Reference
ZS8FL40
Primary DI / UDI-DI
00613994788726
510(k) Number
FDA Product Code
DQY
GMDN Term
Vascular guide-catheter, single-use
Device Class
Class II
Regulation Number
870.1250
GUDID distribution status
Not in Commercial Distribution
Size
Length — 100.0 Centimeter
Catheter Gauge — 8.0 French

Related devices

Cleared under the same submission (K982883)

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No