The following data is part of a premarket notification filed by Polystan C/o Vitalcor, Inc. with the FDA for Polystan Wire Reinforced Catheters And Cannulae.
| Device ID | K872182 |
| 510k Number | K872182 |
| Device Name: | POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE |
| Classification | Catheter, Percutaneous |
| Applicant | POLYSTAN C/O VITALCOR, INC. 100 E. CHESTNUT AVE. Westmont, IL 60559 |
| Contact | Bill Huck |
| Correspondent | Bill Huck POLYSTAN C/O VITALCOR, INC. 100 E. CHESTNUT AVE. Westmont, IL 60559 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-08 |
| Decision Date | 1987-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04037691022499 | K872182 | 000 |
| 04037691016092 | K872182 | 000 |
| 04037691022437 | K872182 | 000 |
| 04037691022444 | K872182 | 000 |
| 04037691022451 | K872182 | 000 |
| 04037691022468 | K872182 | 000 |
| 04037691004303 | K872182 | 000 |
| 04037691021935 | K872182 | 000 |
| 04037691013053 | K872182 | 000 |
| 04037691022031 | K872182 | 000 |
| 04037691022048 | K872182 | 000 |
| 04037691022482 | K872182 | 000 |
| 04037691022024 | K872182 | 000 |