The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Radial Artery Catherization Set With Integral Needle Protection,model Ra-04020-sp.
| Device ID | K021120 |
| 510k Number | K021120 |
| Device Name: | RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP |
| Classification | Catheter, Percutaneous |
| Applicant | ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Debbie Peacock |
| Correspondent | Debbie Peacock ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-08 |
| Decision Date | 2002-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902052170 | K021120 | 000 |
| 20801902136590 | K021120 | 000 |
| 40801902121552 | K021120 | 000 |
| 40801902120227 | K021120 | 000 |
| 40801902114967 | K021120 | 000 |
| 20801902113348 | K021120 | 000 |
| 30801902120220 | K021120 | 000 |
| 20801902193333 | K021120 | 000 |
| 20801902213772 | K021120 | 000 |
| 20801902136620 | K021120 | 000 |
| 20801902139409 | K021120 | 000 |
| 30801902047435 | K021120 | 000 |
| 30801902042539 | K021120 | 000 |
| 30801902028144 | K021120 | 000 |
| 30801902027529 | K021120 | 000 |
| 20801902130956 | K021120 | 000 |
| 20801902130864 | K021120 | 000 |
| 20801902158141 | K021120 | 000 |
| 20801902142195 | K021120 | 000 |
| 20801902215134 | K021120 | 000 |