The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Heartspan Steerable Sheath Introducer.
| Device ID | K170668 |
| 510k Number | K170668 |
| Device Name: | HeartSpan Steerable Sheath Introducer |
| Classification | Introducer, Catheter |
| Applicant | Merit Medical Systems, Inc. 65 Great Valley Parkway Malvern, PA 19355 |
| Contact | Alina Stubbs |
| Correspondent | Alina Stubbs Merit Medical Systems, Inc. 65 Great Valley Parkway 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 | 2017-03-06 |
| Decision Date | 2017-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884450312810 | K170668 | 000 |
| 00884450312803 | K170668 | 000 |
| 00884450312797 | K170668 | 000 |
| 00884450489710 | K170668 | 000 |
| 10884450489724 | K170668 | 000 |
| 10884450484521 | K170668 | 000 |
| 10884450484514 | K170668 | 000 |