Skip to content

Cps Direct™ DS2A004

by St. Jude Medical, Inc.

Ref DS2A004

Cps Direct DS2A004 is a vascular guide-catheter (EU MDR Class I; FDA Class II; FDA product code DQY, Catheter, Percutaneous) made by St. Jude Medical, Inc., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 5415067ALP0005DE), cleared under FDA 510(k) K103250 on 19 Jan 2011 (1 earlier submission) and listed in FDA GUDID since 19 Mar 2015 (UDI-DI 05414734218337), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K103250

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415067ALP0005DE Basic UDI-DI 05414734218337UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05414734218337 UDI-DI Date19 Mar 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK103250 Date19 Jan 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5415067ALP0005DE registered 6 Nov 2026 Active
  • FDA 510(k) K103250 decided 19 Jan 2011 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05414734218337 listed 19 Mar 2015 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K092075
  2. Cleared FDA 510(k) K103250
  3. Listed FDA GUDID 05414734218337
  4. Registered EUDAMED 5415067ALP0005DE

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Cps Direct™
Generic name
Vascular guide-catheter, single-use
Device name
CRM Accessories for Lead Positioning - Bypass Tools
Model / Ref / Catalog
DS2A004
Primary DI / UDI-DI
05414734218337
Basic UDI-DI
5415067ALP0005DE
510(k) Number
FDA product code
DQY
EMDN code
C058001 Adapters and connectors for cardiovascular introducers
GMDN term
Vascular guide-catheter, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1250
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Vascular guide-catheter, single-use

Cleared under the same submission (K092075)

and 8 more cleared under K092075

Cleared under the same submission (K103250)

and 8 more cleared under K103250

Similar devices in this category

Other devices filed under ADAPTERS AND CONNECTORS FOR CARDIOVASCULAR INTRODUCERS.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)