ACS INDEFLATOR PLUS (MODIFICATION #2)
Device Facts
| Record ID | K872981 |
|---|---|
| Device Name | ACS INDEFLATOR PLUS (MODIFICATION #2) |
| Applicant | Advanced Cardiovascular Systems, Inc. |
| Product Code | DXT · Cardiovascular |
| Decision Date | Oct 20, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1650 |
| Device Class | Class 2 |
Regulatory Classification
Special Controls
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
