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Perouse Medical: FDA-registered device maker in FRANCE Oise, France, 5 510(k) clearances

Name: Perouse Medical FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Perouse Medical is registered with the FDA (registration 3006942524) in FRANCE Oise, France. It lists 8 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 11, 2013. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006942524
Address: Route du Manoir Ivry-le-Temple, FRANCE Oise, France, 60173
Owner or operator: Perouse Medical (10024483)
Roles: Manufacturer, Specification developer
First device listed: February 5, 2008
Registered through: 2026
Brand names listed: Dolphin Inflation Device, Inflation System, MyShell Lite, POLYPERF, POLYPERF Safe, POLYSITE Implantable Infusion Port, PPS PI® Pressure Injectable Safety Huber Needle, STERILE NEEDLE GUIDE

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Manufacturer	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Port & Catheter, Implanted, Subcutaneous, Intravascular	LJT	2	Specification developer	accessdata.fda.gov
Port Introducer Kit	OKE	2	Specification developer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Manufacturer	accessdata.fda.gov
Syringe, Balloon Inflation	MAV	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 11, 2013	K122834	POLYSITE IMPLANTABLE INFUSION PORTS	LJT	Substantially Equivalent	Perouse Medical	accessdata.fda.gov
May 2, 2012	K120261	PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER	FPA	Substantially Equivalent	Perouse Medical	accessdata.fda.gov
April 23, 2008	K080472	SEDAT MYSHELL LITE	DTL	Substantially Equivalent	Sedat	accessdata.fda.gov
October 5, 2007	K063631	POLYPERF / POLYPERF SAFE	FPA	Substantially Equivalent	Laboratoires Perouse	accessdata.fda.gov
April 18, 2005	K042449	DOLPHIN INFLATION DEVICE	MAV	Substantially Equivalent	Sedat S.A.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 5, 2017	77100	Class II	Terminated	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.	accessdata.fda.gov
October 6, 2014	69879	Class II	Terminated	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 pr	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	accessdata.fda.gov

Compare with other makers

Updated December 11, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.