The following data is part of a premarket notification filed by Pressure Products Medical Device Manufacturing Llc with the FDA for Safesept Needle Free Transseptal Guidewire.
| Device ID | K172893 |
| 510k Number | K172893 |
| Device Name: | SafeSept Needle Free Transseptal Guidewire |
| Classification | Trocar |
| Applicant | Pressure Products Medical Device Manufacturing LLC 1 School Street Morton, PA 19070 |
| Contact | Andrew Armour |
| Correspondent | Andrew Armour Pressure Products Medical Device Manufacturing LLC 1 School Street Morton, PA 19070 |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-22 |
| Decision Date | 2017-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30858769006112 | K172893 | 000 |