The following data is part of a premarket notification filed by Pulsion Medical Systems Ag with the FDA for Pulsion Pulsiocath Thermodilution Catheters & Accessories.
| Device ID | K072364 |
| 510k Number | K072364 |
| Device Name: | PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES |
| Classification | Probe, Thermodilution |
| Applicant | PULSION MEDICAL SYSTEMS AG 7220 SPARHAWK RD. Wake Forest, NC 27587 |
| Contact | Jamie Sulley |
| Correspondent | Jamie Sulley PULSION MEDICAL SYSTEMS AG 7220 SPARHAWK RD. Wake Forest, NC 27587 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-22 |
| Decision Date | 2007-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24250094500676 | K072364 | 000 |
| 04250094500665 | K072364 | 000 |
| 24250094500652 | K072364 | 000 |
| 04250094500641 | K072364 | 000 |
| 24250094500638 | K072364 | 000 |