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Primum Guiding Catheter 6F Primum EBU3.5

by Pendracare International, B.V. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number08718122008188 UDI-DI Date30 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Primum Guiding Catheter
Generic Name
Vascular guide-catheter, single-use
Model / Ref / Catalog
6F Primum EBU3.5, 26408804
Primary DI / UDI-DI
08718122008188
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
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Catheter Length — 100 Centimeter

Related devices

Cleared under the same submission (K250972)

Show all (11)

Other devices from Pendracare International, B.V.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

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