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Arrow IPN920356

by Teleflex Incorporated

Arrow IPN920356 (AI-01500-E) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K883905 on 19 Jan 1989 and listed in FDA GUDID since 8 Nov 2022 (UDI-DI 10801902193992), active as of 23 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 23 Oct 2026

Documents

510(k) K883905

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10801902193992 UDI-DI Date8 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESD from GUDID Substantially Equivalent — Deferred · Traditional NumberK883905 Date19 Jan 1989DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K883905 decided 19 Jan 1989 Active
  • FDA GUDID UDI-DI 10801902193992 listed 8 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K883905
  2. Listed FDA GUDID 10801902193992

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Arrow
Generic name
Pneumothorax catheter insertion set
Model / Ref / Catalog
IPN920356, AI-01500-E
Primary DI / UDI-DI
10801902193992
510(k) Number
FDA product code
JOL
GMDN term
Pneumothorax catheter insertion set
Device class
Class II
Regulation number
880.6740
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pneumothorax catheter insertion set

Cleared under the same submission (K883905)

Similar devices in this category

Other devices filed under Pneumothorax catheter insertion set.

Other devices from Teleflex Incorporated

  • Arrow IPNB00820 Open recall

    Class II

  • Arrow IPNB00826 Open recall

    Class II

  • Arrow IPNB00822 Open recall

    Class II

  • Arrow IPNB00827 Open recall

    Class II

See all devices from Teleflex Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Contains latex
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)