The following data is part of a premarket notification filed by Retractable Technologies, Inc. with the FDA for Vanishpoint I.v. Catheter.
| Device ID | K081420 |
| 510k Number | K081420 |
| Device Name: | VANISHPOINT I.V. CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. Little Elm, TX 75068 -0009 |
| Contact | Rhonda Wells |
| Correspondent | Rhonda Wells RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. Little Elm, TX 75068 -0009 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-20 |
| Decision Date | 2008-11-07 |
| Summary: | summary |