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Guidewire SGW-066-07

by Galt Medical Corp.

Ref SGW-066-07

Guidewire SGW-066-07 (SW30-140) is a device classified as Class III in the EU and Class II in the US made by Galt Medical Corp., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-00841268107021), cleared under FDA 510(k) K021990 on 18 Jul 2002 and listed in FDA GUDID since 9 Aug 2017 (UDI-DI 00841268107021), active as of 7 Nov 2026. One FDA recall is linked to it.

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K021990

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841268107021 Basic UDI-DI 00841268107021UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841268107021 UDI-DI Date9 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK021990 Date18 Jul 2002IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00841268107021 registered 3 Nov 2026 Active
  • FDA 510(k) K021990 decided 18 Jul 2002 Active
  • FDA GUDID UDI-DI 00841268107021 listed 9 Aug 2017 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2917-2026 FDA Class II initiated 26 Jun 2026

    Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

Timeline

4 dated events

  1. Cleared FDA 510(k) K021990
  2. Listed FDA GUDID 00841268107021
  3. Recall initiated FDA recalls Z-2917-2026
  4. Registered EUDAMED B-00841268107021

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  • Withdrawn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
Guidewire
Generic name
Peripheral vascular guidewire, manual
Model / Ref / Catalog
SGW-066-07, SW30-140
Primary DI / UDI-DI
00841268107021
Basic UDI-DI
B-00841268107021
FDA product code
DQX
EMDN code
C04020199 Peripheral vascular diagnostic guidewires- other
GMDN term
Peripheral vascular guidewire, manual
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.1330
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide
Size
Outer Diameter — 0.030 Inch

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00841268107021: EUDAMED states No, FDA GUDID states Yes.

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.

Related devices

Category: Peripheral vascular guidewire, manual

Cleared under the same submission (K021990)

and 8 more cleared under K021990

Other devices from Galt Medical Corp.

See all devices from Galt Medical Corp. →

Properties

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