The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Heartspan Steerable Introducer Kit.
| Device ID | K132164 |
| 510k Number | K132164 |
| Device Name: | HEARTSPAN STEERABLE INTRODUCER KIT |
| Classification | Introducer, Catheter |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 65 GREAT VALLEY PAKRWAY Malvern, PA 19355 |
| Contact | Alina Stubbs |
| Correspondent | Alina Stubbs MERIT MEDICAL SYSTEMS, INC. 65 GREAT VALLEY PAKRWAY Malvern, PA 19355 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-12 |
| Decision Date | 2013-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884450198520 | K132164 | 000 |
| 00884450198490 | K132164 | 000 |
| 00884450198483 | K132164 | 000 |