The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Vascular Sono.
| Device ID | K113196 |
| 510k Number | K113196 |
| Device Name: | VASCULAR SONO |
| Classification | Introducer, Catheter |
| Applicant | PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 1 Geisingen, DE 78187 |
| Contact | Christian G Quass |
| Correspondent | Christian G Quass PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 1 Geisingen, DE 78187 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-31 |
| Decision Date | 2012-02-06 |
| Summary: | summary |