The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Ultra 8 Intra-aortic Balloon Catheters (iabs) 8fr 30cc And 40cc Universal.
| Device ID | K000729 |
| 510k Number | K000729 |
| Device Name: | ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL |
| 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 | 2000-03-06 |
| Decision Date | 2000-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801902136701 | K000729 | 000 |
| 20801902145615 | K000729 | 000 |
| 10801902145748 | K000729 | 000 |
| 10801902145731 | K000729 | 000 |
| 10801902145687 | K000729 | 000 |
| 10801902145670 | K000729 | 000 |
| 10801902145625 | K000729 | 000 |
| 10801902145618 | K000729 | 000 |
| 10801902142402 | K000729 | 000 |
| 10801902161922 | K000729 | 000 |
| 10801902161946 | K000729 | 000 |
| 10801902161984 | K000729 | 000 |
| 20801902145622 | K000729 | 000 |
| 20801902145677 | K000729 | 000 |
| 20801902145684 | K000729 | 000 |
| 00801902136695 | K000729 | 000 |
| 30801902028007 | K000729 | 000 |
| 00801902026804 | K000729 | 000 |
| 00801902010759 | K000729 | 000 |
| 00801902010742 | K000729 | 000 |
| 00801902003751 | K000729 | 000 |
| 10801902142433 | K000729 | 000 |
| 20801902145769 | K000729 | 000 |
| 20801902145752 | K000729 | 000 |
| 20801902145745 | K000729 | 000 |
| 20801902145738 | K000729 | 000 |
| 10801902161939 | K000729 | 000 |