The following data is part of a premarket notification filed by Pressure Products Medical Device Manufacturing Llc with the FDA for Tsi Transseptal Introducer.
| Device ID | K181031 |
| 510k Number | K181031 |
| Device Name: | TSI Transseptal Introducer |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-18 |
| Decision Date | 2018-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30858769006341 | K181031 | 000 |
| 30858769006334 | K181031 | 000 |
| 30858769006327 | K181031 | 000 |
| 30858769006310 | K181031 | 000 |
| 30858769006303 | K181031 | 000 |
| 30858769006297 | K181031 | 000 |
| 30858769006280 | K181031 | 000 |
| 30858769006273 | K181031 | 000 |