The following data is part of a premarket notification filed by Pressure Products Medical Device Manufacturing Llc with the FDA for Tsn Transseptal Needle.
| Device ID | K172950 |
| 510k Number | K172950 |
| Device Name: | TSN Transseptal Needle |
| 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 | 2017-09-26 |
| Decision Date | 2018-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30858769006259 | K172950 | 000 |
| 30858769006242 | K172950 | 000 |
| 00858769006234 | K172950 | 000 |
| 30858769006211 | K172950 | 000 |
| 30858769006204 | K172950 | 000 |
| 30858769006198 | K172950 | 000 |