510(k) K042449 ยท MAV Syringe, Balloon Inflation
DOLPHIN INFLATION DEVICE
| Applicant | Sedat S.A., Temecula CA, US |
| Decision | Substantially Equivalent, Apr 18, 2005 |
| Received | Sep 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042449
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2017 | DeRoyal Industries Inc DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO,
Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control Terminated |
MAV | None listed |
| Apr 12, 2017 | Vascular Solutions, Inc. Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide.
DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and de Terminated |
MAV | None listed |
| Apr 5, 2017 | PEROUSE MEDICAL DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND Terminated |
MAV | None listed |
| Dec 29, 2014 | PEROUSE MEDICAL Bard Caliber (CL3030) Inflation Device
Product Usage:
Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation de Terminated |
MAV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.