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Arrow IPN037697

by Teleflex Incorporated 3 variants

Arrow IPN037697 (CDC-41541-MPK1A) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K161313 on 24 Aug 2016 and listed in FDA GUDID since 30 Mar 2017 (UDI-DI 10801902130157), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K161313

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 Number10801902130157 UDI-DI Date30 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161313 Date24 Aug 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161313 decided 24 Aug 2016 Active
  • FDA GUDID UDI-DI 10801902130157 listed 30 Mar 2017 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0102-2023 FDA Class II initiated 14 Sep 2022

    Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).

    • Terminated Z-1818-2019 FDA Class II initiated 23 Apr 2019

    Lidstock states the incorrect expiration date for the product

Timeline

4 dated events

  1. Cleared FDA 510(k) K161313
  2. Listed FDA GUDID 10801902130157
  3. Recall initiated FDA recalls Z-1818-2019
  4. Recall initiated FDA recalls Z-0102-2023

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  • Withdrawn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
Peripheral vascular catheter
Model / Ref / Catalog
IPN037697, CDC-41541-MPK1A
Primary DI / UDI-DI
10801902130157
510(k) Number
FDA product code
PND
GMDN term
Peripheral vascular catheter
Device class
Class II
Regulation number
880.5200
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Peripheral vascular catheter

Cleared under the same submission (K161313)

and 8 more cleared under K161313

Similar devices

Other devices filed under FDA product code PND (Midline catheter).

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
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)