The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Fountain Infusion System.
| Device ID | K991619 |
| 510k Number | K991619 |
| Device Name: | FOUNTAIN INFUSION SYSTEM |
| Classification | Catheter, Continuous Flush |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Chester Mccoy |
| Correspondent | Chester Mccoy MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-11 |
| Decision Date | 1999-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450030391 | K991619 | 000 |
| 10884450019501 | K991619 | 000 |
| 10884450019525 | K991619 | 000 |
| 10884450021665 | K991619 | 000 |
| 10884450021672 | K991619 | 000 |
| 10884450021689 | K991619 | 000 |
| 10884450021696 | K991619 | 000 |
| 10884450024314 | K991619 | 000 |
| 10884450024321 | K991619 | 000 |
| 10884450028213 | K991619 | 000 |
| 10884450028220 | K991619 | 000 |
| 10884450028237 | K991619 | 000 |
| 10884450029951 | K991619 | 000 |
| 10884450030384 | K991619 | 000 |
| 10884450433871 | K991619 | 000 |