Pertrach 301-D4553
by Engineered Medical Systems, LLC
Pertrach 301-D4553 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 00841470104344), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00841470104344 | Date27 May 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK914743 | Date10 Jul 1992 | StatusActive |
Official records
- AccessGUDID record 00841470104344
- FDA 510(k) database K914743
Across registries
- FDA 510(k) K914743 decided 10 Jul 1992 Active
- FDA GUDID UDI-DI 00841470104344 listed 27 May 2016 Listed
Timeline
- Cleared FDA 510(k) K914743
- Listed FDA GUDID 00841470104344
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pertrach
- Generic name
- Cricothyrotomy kit, single-use
- Model / reference
- 301-D4553
- Primary DI / UDI-DI
- 00841470104344
- 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 — 3.0 Millimeter