The following data is part of a premarket notification filed by Pertrach with the FDA for Emergency Percutaneous Cricothyroidotomy Kit,modif.
| Device ID | K914743 |
| 510k Number | K914743 |
| Device Name: | EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | PERTRACH BOX 1158 109 KELLY DR. Bridgeport, WV 26330 |
| Contact | Frederic J Toye |
| Correspondent | Frederic J Toye PERTRACH BOX 1158 109 KELLY DR. Bridgeport, WV 26330 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-11 |
| Decision Date | 1992-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889942318674 | K914743 | 000 |
| 10841470100091 | K914743 | 000 |
| 10841470100084 | K914743 | 000 |
| 10841470100077 | K914743 | 000 |
| 10841470100060 | K914743 | 000 |
| 10841470100053 | K914743 | 000 |
| 10841470100046 | K914743 | 000 |
| 10841470100039 | K914743 | 000 |
| 10841470100022 | K914743 | 000 |
| 10841470100107 | K914743 | 000 |
| 10841470104310 | K914743 | 000 |
| 10841470104396 | K914743 | 000 |
| 10841470104389 | K914743 | 000 |
| 10841470104372 | K914743 | 000 |
| 10841470104365 | K914743 | 000 |
| 10841470104358 | K914743 | 000 |
| 10841470104341 | K914743 | 000 |
| 10841470104334 | K914743 | 000 |
| 10841470104327 | K914743 | 000 |
| 10841470100015 | K914743 | 000 |