The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow 18ga Two-lumen Intravenous Cath/23ga Needle.
| Device ID | K862153 |
| 510k Number | K862153 |
| Device Name: | ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
| Contact | Ronald P Citron |
| Correspondent | Ronald P Citron ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-05 |
| Decision Date | 1986-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902001024 | K862153 | 000 |
| 30801902001017 | K862153 | 000 |
| 40801902001021 | K862153 | 000 |
| 50801902001011 | K862153 | 000 |
| 30801902196706 | K862153 | 000 |
| 30801902196690 | K862153 | 000 |
| 30801902210488 | K862153 | 000 |
| 30801902210471 | K862153 | 000 |