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SSPC Delivery Catheter

by CenterPoint Systems LLC 3 variants

Ref 9183

SSPC Delivery Catheter (9183) is a pacing/defibrillation lead delivery catheter (EU MDD Class III; FDA Class II; FDA product code DQY, Catheter, Percutaneous) made by CenterPoint Systems LLC, registered in EUDAMED on 15 Nov 2022 (Basic UDI-DI B-00810024670031), cleared under FDA 510(k) K190475 on 28 Jun 2019 and listed in FDA GUDID since 21 Aug 2019 (UDI-DI 00810024670031), active as of 22 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190475

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00810024670031 Basic UDI-DI 00810024670031UDI-DIDate15 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00810024670031 UDI-DI Date21 Aug 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK190475 Date28 Jun 2019IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00810024670031 registered 15 Nov 2022 Active
  • FDA 510(k) K190475 decided 28 Jun 2019 Active
  • FDA GUDID UDI-DI 00810024670031 listed 21 Aug 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K190475
  2. Listed FDA GUDID 00810024670031
  3. Registered EUDAMED B-00810024670031

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
SSPC Delivery Catheter EUDAMED
SSPC3 Delivery Catheter GUDID
Generic name
Pacing/defibrillation lead delivery catheter
Model / reference
9183
Primary DI / UDI-DI
00810024670031 EUDAMED
00810024671830 GUDID
Basic UDI-DI
B-00810024670031
510(k) Number
FDA product code
DQY
EMDN code
C0502 Cardiovascular introducer sheaths, valved
GMDN term
Pacing/defibrillation lead delivery catheter
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.1250
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Catheter Working Length — 40 Centimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00810024670031
GUDID
00810024671830
Device classEUDAMED
Class III
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00810024670031; FDA GUDID lists 00810024671830), so their flags are not compared. Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000009054
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Related devices

Category: Vascular catheter introduction set, nonimplantable

Similar devices in this category

Other devices filed under CARDIOVASCULAR INTRODUCER SHEATHS, VALVED.

Other devices from CenterPoint Systems LLC

See all devices from CenterPoint Systems LLC →

Properties

  • Supplied sterile
  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)