Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011773324

FEI Number

3011773324

Entity Name

Haemonetics Corporation

City/State/Country

Salt Lake City, UT, US

Establishment Address

1555 South Gramercy Rd, Ste 500, Salt Lake City, UT 84104, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Haemonetics Corporation (Owner Number: 1219343)

Owner / Operator Contact Address

125 Summer St, Boston, MA 02110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101907

PMA Number

N/A

All Registered Proprietary Names

Cell Saver Elite

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2011-01-24

Official Correspondent

Julie Ryan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Haemonetics Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011538588	Haemonetics Malaysia Sdn Bhd	Penang Pulau Pinang, MY
9617787	Haemonetics Mexico Manufacturing S. de R.L. de C.V.	TIJUANA, B.C. Mexico, MX
3019849102	Haemonetics Corporation	Clinton, PA, US
1219343	HAEMONETICS CORPORATION	Boston, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881350	Stryker Corp.	CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM	1988-09-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

Similar Registrations

Registration Number	Establishment Name	Location
9611109	LivaNova Deutschland GmbH	MUNCHEN Bavaria, DE
3008810357	Clinico Medical Sp. z o.o.	Blonie/Miekinia Dolnoslaskie, PL
3007923088	Sanmina-SCI Systems (Malaysia) Sdn Bhd	Perai Pulau Pinang, MY
9680841	SORIN GROUP ITALIA S.R.L	MIRANDOLA Modena, IT
3006654680	Miller Technical Services	Plymouth, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011773324. Last updated year: 2026. Please use registration number 3011773324 when referencing this establishment in official correspondence.