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Pertrach 301-D4555

by Engineered Medical Systems, LLC

Pertrach 301-D4555 is a Class II device made by Engineered Medical Systems, LLC, cleared under FDA 510(k) K914743 on 10 Jul 1992 and listed in FDA GUDID since 27 May 2016 (UDI-DI 00841470104320), 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) K914743

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 Number00841470104320 UDI-DI Date27 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK914743 Date10 Jul 1992DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K914743 decided 10 Jul 1992 Active
  • FDA GUDID UDI-DI 00841470104320 listed 27 May 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K914743
  2. Listed FDA GUDID 00841470104320

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pertrach
Generic name
Cricothyrotomy kit, single-use
Model / reference
301-D4555
Primary DI / UDI-DI
00841470104320
510(k) Number
FDA product code
BTO
GMDN term
Cricothyrotomy kit, single-use
Device class
Class II
Regulation number
868.5800
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 3.5 Millimeter

Related devices

Category: Cricothyrotomy kit, single-use

Cleared under the same submission (K914743)

and 8 more cleared under K914743

Similar devices

Other devices filed under FDA product code BTO (Tube, Tracheostomy (W/Wo Connector)).

Other devices from Engineered Medical Systems, LLC

See all devices from Engineered Medical Systems, LLC →

Properties

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