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Selectiva 1806004A

by Heraeus Medical Components LLC

Selectiva 1806004A is a Class II device made by Heraeus Medical Components LLC, cleared under FDA 510(k) K013024 on 4 Dec 2001 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00857834006629), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K013024

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857834006629 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK013024 Date4 Dec 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K013024 decided 4 Dec 2001 Active
  • FDA GUDID UDI-DI 00857834006629 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K013024
  2. Listed FDA GUDID 00857834006629

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Selectiva
Generic name
Peripheral vascular guidewire, manual
Model / reference
1806004A
Primary DI / UDI-DI
00857834006629
510(k) Number
FDA product code
DQX
GMDN term
Peripheral vascular guidewire, manual
Device class
Class II
Regulation number
870.1330
GUDID distribution status
In Commercial Distribution

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Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)