Datascope Corp. · Class II · Cleared Nov 2, 2001
| K-number | K013326 |
| Device name | MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B |
| Applicant | Datascope Corp. |
| Product code | DSP |
| Device class | Class II |
| Decision date | Nov 2, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 870.3535 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov