Data / Medical devices / Mexico / Haemonetics Mexico Manufacturing S. de R.L. de C.V.

Haemonetics Mexico Manufacturing S. de R.L. de C.V.: FDA-registered device maker in TIJUANA, B.C. Mexico, Mexico, 6 510(k) clearances

Name: Haemonetics Mexico Manufacturing S. de R.L. de C.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Haemonetics Mexico Manufacturing S. de R.L. de C.V. is registered with the FDA (registration 9617787) in TIJUANA, B.C. Mexico, Mexico. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 3, 2010. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 9617787
FEI number: 3003327833
Address: Calle Colinas No. 11731 Secc. Colinas Parque Industrial el Florido, TIJUANA, B.C. Mexico, Mexico, C.P. 22244
Owner or operator: Haemonetics Corporation (1219343)
Roles: Manufacturer
First device listed: November 6, 2008
Registered through: 2026
Brand names listed: ACP215, Cell Saver 5, Cell Saver 5, Cell Saver 5+, Cell Saver Elite, Cymbal, Haemonetics Model 215 Automated Glycerolization/Deglycerolization and Cell Washing System, MCS+8150 Apheresis System, MCS+9000, SDP revision E software, 994CF-CPP series disposable sets and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Autotransfusion	CAC	2	Manufacturer	accessdata.fda.gov
Container, Empty, For Collection & Processing Of Blood & Blood Components	KSR	2	Manufacturer	accessdata.fda.gov
Pump, Infusion	FRN	2	Manufacturer	accessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)	BTA	2	Manufacturer	accessdata.fda.gov
Separator, Automated, Blood Cell And Plasma, Therapeutic	LKN	U	Manufacturer	accessdata.fda.gov
Separator, Automated, Blood Cell, Diagnostic	GKT	2	Manufacturer	accessdata.fda.gov
System, Processing For Frozen Blood	KSW	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 3, 2010	K101907	HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM	CAC	Substantially Equivalent	Haemonetics Corp.	accessdata.fda.gov
October 5, 2005	K052626	SMARTSUCTION HARMONY DEVICE	BTA	Substantially Equivalent	Haemonetics Corp.	accessdata.fda.gov
January 8, 2002	K014083	HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM	CAC	Substantially Equivalent	Haemonetics Corp.	accessdata.fda.gov
June 4, 1996	K953681	HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET	LKN	Substantially Equivalent	Haemonetics Corp.	accessdata.fda.gov
January 5, 1994	K932890	CELL SAVER 5 SYSTEM	CAC	Substantially Equivalent	Haemonetics Corp.	accessdata.fda.gov
December 9, 1985	K852645	FLUID MANAGEMENT SYSTEM	FRN	Substantially Equivalent	Haemonetics Corp.	accessdata.fda.gov

Compare with other makers

Updated December 3, 2010. 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.