The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrowgard Blue Quad-lumen Central Venous Catheter.
| Device ID | K962577 |
| 510k Number | K962577 |
| Device Name: | ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | ARROW INTL., INC. 3000 BERNVILLE RD. Reading, PA 19605 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel ARROW INTL., INC. 3000 BERNVILLE RD. Reading, PA 19605 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-01 |
| Decision Date | 1997-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902111402 | K962577 | 000 |
| 20801902009108 | K962577 | 000 |
| 30801902116940 | K962577 | 000 |
| 20801902138952 | K962577 | 000 |
| 40801902117456 | K962577 | 000 |
| 20801902057048 | K962577 | 000 |
| 30801902003219 | K962577 | 000 |
| 40801902122351 | K962577 | 000 |
| 40801902119047 | K962577 | 000 |
| 40801902116947 | K962577 | 000 |
| 20801902069386 | K962577 | 000 |
| 20801902187486 | K962577 | 000 |
| 20801902097273 | K962577 | 000 |
| 20801902102342 | K962577 | 000 |
| 30801902102349 | K962577 | 000 |
| 30801902097270 | K962577 | 000 |
| 30801902097164 | K962577 | 000 |
| 30801902069383 | K962577 | 000 |
| 30801902057045 | K962577 | 000 |
| 30801902009273 | K962577 | 000 |
| 30801902009105 | K962577 | 000 |
| 30801902006517 | K962577 | 000 |
| 30801902006296 | K962577 | 000 |
| 30801902006166 | K962577 | 000 |
| 10801902009279 | K962577 | 000 |
| 20801902172512 | K962577 | 000 |