The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Ac 3 Lumen Central Venous Access Kit With Arrowg+ard Antimicrobial Surface.
| Device ID | K032962 |
| 510k Number | K032962 |
| Device Name: | AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Elizabeth Price |
| Correspondent | Elizabeth Price ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-09-23 |
| Decision Date | 2003-10-29 |
| Summary: | summary |