The following data is part of a premarket notification filed by Alseal with the FDA for Hqs Introducer (model 2064-hqs).
| Device ID | K153494 |
| 510k Number | K153494 |
| Device Name: | HQS Introducer (Model 2064-HQS) |
| Classification | Introducer, Catheter |
| Applicant | ALSEAL 2, RUE DU PROFESSEUR MILLERET Besancon, FR 25000 |
| Contact | Jean-francois M Delforge |
| Correspondent | Yolanda Smith SMITH ASSOCIATES 1468 HARWELL AVE Crofton, MD 21114 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-04 |
| Decision Date | 2016-08-25 |
| Summary: | summary |