Company ยท FR
Perouse Medical
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2013. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 11, 2013 | K122834 | POLYSITE IMPLANTABLE INFUSION PORTS Perouse Medical, FR | LJT |
| Nov 28, 2012 | K123035 | SEAL ONE Perouse Medical, FR | DXC |
| May 2, 2012 | K120261 | PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER Perouse Medical, FR | FPA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K042449 |
| Dec 29, 2014 | PEROUSE MEDICAL Synthes Inflation System (03.804.4135)
Product Usage:
Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressu Terminated |
MAV | K110604 |
| 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 | K042449 |
| Jul 22, 2014 | Perouse Medical Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter. Terminated |
MAV | K082755 |