Heart Technology Mfg., Inc. · Class II · Cleared Jan 18, 1996
| K-number | K954604 |
| Device name | ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY |
| Applicant | Heart Technology Mfg., Inc. |
| Product code | MCW |
| Device class | Class II |
| Decision date | Jan 18, 1996 |
| Decision | Substantially Equivalent |
| Regulation | 870.4875 |
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