The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow-clarke(tm) Pleura-seal(tm) Thoracentesis Kit.
| Device ID | K870572 |
| 510k Number | K870572 |
| Device Name: | ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT |
| Classification | Catheter And Tip, Suction |
| Applicant | ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-10 |
| Decision Date | 1987-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902099588 | K870572 | 000 |
| 20801902120124 | K870572 | 000 |
| 30801902120138 | K870572 | 000 |
| 10801902097962 | K870572 | 000 |
| 10801902002690 | K870572 | 000 |
| 20801902145820 | K870572 | 000 |
| 20801902145127 | K870572 | 000 |
| 20801902142911 | K870572 | 000 |
| 40801902114868 | K870572 | 000 |
| 20801902209010 | K870572 | 000 |
| 20801902120193 | K870572 | 000 |
| 50801902004791 | K870572 | 000 |
| 30801902097966 | K870572 | 000 |
| 30801902079894 | K870572 | 000 |
| 30801902043840 | K870572 | 000 |
| 30801902004797 | K870572 | 000 |
| 30801902004780 | K870572 | 000 |
| 30801902002700 | K870572 | 000 |
| 30801902002694 | K870572 | 000 |
| 50801902120132 | K870572 | 000 |
| 70801902004795 | K870572 | 000 |
| 20801902197973 | K870572 | 000 |