The following data is part of a premarket notification filed by Seven Sons Ltd. with the FDA for Stent Positioning Assistance System (spas).
| Device ID | K221917 |
| 510k Number | K221917 |
| Device Name: | Stent Positioning Assistance System (SPAS) |
| Classification | Wire, Guide, Catheter |
| Applicant | Seven Sons Ltd. 65 Yigal Alon Street Tel Aviv, IL 67443 |
| Contact | Nancy Zhang |
| Correspondent | Nancy Zhang Seven Sons Ltd. 65 Yigal Alon Street Tel Aviv, IL 67443 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-30 |
| Decision Date | 2022-08-19 |