The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Captiva Blood Containment Device Cn100, Can19t71w.
| Device ID | K031922 |
| 510k Number | K031922 |
| Device Name: | CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W |
| Classification | Introducer, Catheter |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | John W Nicholson |
| Correspondent | John W Nicholson MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-23 |
| Decision Date | 2003-10-01 |
| Summary: | summary |