The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow-howes Large Bore Multi-lumen Central Venous Catheters.
| Device ID | K970864 |
| 510k Number | K970864 |
| Device Name: | ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS |
| 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 | 1997-03-10 |
| Decision Date | 1997-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902102165 | K970864 | 000 |
| 80801902129259 | K970864 | 000 |
| 20801902001157 | K970864 | 000 |
| 20801902099673 | K970864 | 000 |
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| 40801902122085 | K970864 | 000 |
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| 20801902097105 | K970864 | 000 |
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| 50801902122082 | K970864 | 000 |
| 50801902121948 | K970864 | 000 |
| 30801902122088 | K970864 | 000 |
| 30801902121944 | K970864 | 000 |
| 20801902187592 | K970864 | 000 |