Datascope Corp., Cardiac Assist Division · Class II · Cleared Jun 18, 2009
| K-number | K091449 |
| Device name | DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 |
| Applicant | Datascope Corp., Cardiac Assist Division |
| Product code | DSP |
| Device class | Class II |
| Decision date | Jun 18, 2009 |
| 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