The following data is part of a premarket notification filed by Polystan A/s with the FDA for Pediatric Arterial Cannula.
| Device ID | K023251 |
| 510k Number | K023251 |
| Device Name: | PEDIATRIC ARTERIAL CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | POLYSTAN A/S WALGERHOLM 8 Vaerlose, DK Dk-3500 |
| Contact | Dana Olsen |
| Correspondent | Dana Olsen POLYSTAN A/S WALGERHOLM 8 Vaerlose, DK Dk-3500 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-30 |
| Decision Date | 2002-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04037691011233 | K023251 | 000 |
| 04037691018034 | K023251 | 000 |
| 04037691022840 | K023251 | 000 |
| 04037691022833 | K023251 | 000 |
| 04037691018065 | K023251 | 000 |
| 04037691021867 | K023251 | 000 |
| 04037691022826 | K023251 | 000 |
| 04037691011240 | K023251 | 000 |