Perouse Medical
FRANCE Oise, FR
Perouse Medical appears in FDA device records in FRANCE Oise, FR. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Perouse Medical between 2012 and 2013. The busiest year on record is 2012, with 2. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 2 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K122834 | POLYSITE IMPLANTABLE INFUSION PORTS | LJT | Substantially Equivalent | |
| K123035 | SEAL ONE | DXC | Substantially Equivalent | |
| K120261 | PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006942524 | 3006942524 | Perouse Medical | Route du Manoir, FRANCE Oise 60173 FR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- DXCClamp, Vascular
- GDFGuide, Needle, Surgical
- FMINeedle, Hypodermic, Single Lumen
- LXHOrthopedic Manual Surgical Instrument
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- OKEPort Introducer Kit
- FPASet, Administration, Intravascular
- MAVSyringe, Balloon Inflation
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1891-2017 | DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND | Complaints regarding broken blister. | Class II | Terminated | |
| Z-0877-2015 | 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 pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter | Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure | Class II | Terminated | |
| Z-0876-2015 | 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 device for angioplasty procedures | Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure | Class II | Terminated | |
| Z-2089-2014 | Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter. | Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devices due to a potential water-tightness default. The potential default could cause an air entry when the plunger is positioned around 20 mL. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain