NKU · Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
Cardiovascular · 21 CFR 870.1650 · Class 2
Overview
| Product Code | NKU |
|---|---|
| Device Name | Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed |
| Regulation | 21 CFR 870.1650 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K053188 | REPROCESSED BALOON INFLATION DEVICE | Sterilmed, Inc. | May 4, 2006 | SESE |
Top Applicants
- Sterilmed, Inc. — 1 clearance
