SafeSept® Transseptal Guidewire (SS-140)
Trocar
Pressure Products Medical Device Manufacturing LLC.
The following data is part of a premarket notification filed by Pressure Products Medical Device Manufacturing Llc. with the FDA for Safesept® Transseptal Guidewire (ss-140).
Pre-market Notification Details
| Device ID | K221707 |
| 510k Number | K221707 |
| Device Name: | SafeSept® Transseptal Guidewire (SS-140) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-13 |
| Decision Date | 2022-09-14 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30858769006419 | K221707 | 000 |
Trademark Results [SafeSept]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SAFESEPT 87249371 5232606 Live/Registered |
Pressure Products Medical Supplies Inc. 2016-11-28 |
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