The following data is part of a premarket notification filed by Alseal with the FDA for Hqs Introducer.
| Device ID | K113849 |
| 510k Number | K113849 |
| Device Name: | HQS INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | ALSEAL ESPACE VALENTIN- VALPARC 6C, RUE DE FRANCHE-COMTE Besancon, FR 25048 |
| Contact | Jean-francois Delforge |
| Correspondent | Paula Wilkerson INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-12-29 |
| Decision Date | 2012-07-31 |
| Summary: | summary |