The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Rediguard, 9fr. 50cc, Intra-aortic Balloon Vatheter, Iab-r950-u.
| Device ID | K010330 |
| 510k Number | K010330 |
| Device Name: | ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | ARROW INTL., INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Contact | William Paquin |
| Correspondent | William Paquin ARROW INTL., INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-02 |
| Decision Date | 2001-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902010880 | K010330 | 000 |
| 30801902010859 | K010330 | 000 |
| 00801902010803 | K010330 | 000 |
| 10801902145601 | K010330 | 000 |
| 10801902145595 | K010330 | 000 |
| 10801902142389 | K010330 | 000 |
| 10801902161953 | K010330 | 000 |
| 20801902182870 | K010330 | 000 |
| 20801902182849 | K010330 | 000 |