The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for 19 Ga Plastic Reinforced Epidural Catheter.
| Device ID | K001587 |
| 510k Number | K001587 |
| Device Name: | 19 GA PLASTIC REINFORCED EPIDURAL CATHETER |
| Classification | Anesthesia Conduction Kit |
| Applicant | ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-23 |
| Decision Date | 2000-07-12 |