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primeMidline PFM3SML20

by Pfm Medical Incorporated

primeMidline PFM3SML20 is a central venous catheterization kit (FDA Class II; FDA product code PND, Midline Catheter) made by Pfm Medical Incorporated, cleared under FDA 510(k) K173114 on 7 Mar 2018 and listed in FDA GUDID since 25 Apr 2018 (UDI-DI 00813623011588), 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) K173114

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 Number00813623011588 UDI-DI Date25 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173114 Date7 Mar 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173114 decided 7 Mar 2018 Active
  • FDA GUDID UDI-DI 00813623011588 listed 25 Apr 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173114
  2. Listed FDA GUDID 00813623011588

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
primeMidline
Generic name
Central venous catheterization kit, short-term
Model / Ref / Catalog
PFM3SML20
Primary DI / UDI-DI
00813623011588
510(k) Number
FDA product code
PND
GMDN term
Central venous catheterization kit, short-term
Device class
Class II
Regulation number
880.5200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Central venous catheterization kit, short-termPeripheral vascular catheter

Cleared under the same submission (K173114)

and 1 more cleared under K173114

Similar devices

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

Other devices from Pfm Medical Incorporated

See all devices from Pfm Medical Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)