Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010617000

FEI Number

3003793491

Entity Name

ZOLL Circulation, Inc.

City/State/Country

San Jose, CA, US

Establishment Address

2000 Ringwood Ave, San Jose, CA 95131, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

ZOLL Medical Corporation (Owner Number: 1220908)

Owner / Operator Contact Address

269 MILL ROAD, Chelmsford, MA 01824, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150046

PMA Number

N/A

All Registered Proprietary Names

Autopulse Resuscitation System Model 100 Icy Model Catheter Cool Line Catheter ICY Catheter, Quattro Catheter, Cool Line Catheter Thermogard XP Console Thermogard HQ Console Thermogard HQ Thermogard XP CoolGard 3000 Solex Intravascular Heat Exchange Catheter AutoPulse Recusitation System Model 100, AutoPulse Lithium-Ion Battery, AutoPulse Multi-Chemistry Battery Charger Start-Up Kit (SUK) ICY® Intravascular Heat Exchange Catheter Quattro Intravascular Heat Exchange Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRM	Compressor, Cardiac, External	Cardiovascular	Class 2	870.5200	2013-12-06
NCX	System, Hypothermia, Intravenous, Cooling	Cardiovascular	Class 2	870.5900	2009-05-08
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2025-11-25
NZE	Hyperthermia Monitor	Cardiovascular	Class 2	870.5900	2025-11-25
NCX	System, Hypothermia, Intravenous, Cooling	Cardiovascular	Class 2	870.5900	2017-05-12
NCX	System, Hypothermia, Intravenous, Cooling	Cardiovascular	Class 2	870.5900	2009-05-08
NCX	System, Hypothermia, Intravenous, Cooling	Cardiovascular	Class 2	870.5900	2009-05-08
DRM	Compressor, Cardiac, External	Cardiovascular	Class 2	870.5200	2023-08-03
NCX	System, Hypothermia, Intravenous, Cooling	Cardiovascular	Class 2	870.5900	2022-06-08
NCX	System, Hypothermia, Intravenous, Cooling	Cardiovascular	Class 2	870.5900	2012-11-29
NCX	System, Hypothermia, Intravenous, Cooling	Cardiovascular	Class 2	870.5900	2023-12-14
NCX	System, Hypothermia, Intravenous, Cooling	Cardiovascular	Class 2	870.5900	2009-05-08
NCX	System, Hypothermia, Intravenous, Cooling	Cardiovascular	Class 2	870.5900	2014-10-28
DRM	Compressor, Cardiac, External	Cardiovascular	Class 2	870.5200	2012-11-29
NCX	System, Hypothermia, Intravenous, Cooling	Cardiovascular	Class 2	870.5900	2017-05-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ZOLL Medical 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
1218058	ZOLL Medical Corporation	Pawtucket, RI, US
2112020	ZOLL Medical Corporation	DEERFIELD, WI, US
2021710	ZOLL Palm Springs	Palm Springs, CA, US
3038259592	ZOLL MEDICAL CORPORATION	Wilmington, MA, US
3029871637	ZOLL International Holding B.V.	Elst Gelderland, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171373	3M Company	3M Bair Hugger Model 675 Total Temperature Management System	2017-10-10
K083336	Smiths Medical Asd, Inc.	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	2009-06-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2022	ZOLL Circulation, Inc.	2	Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237
Z-0040-2022	ZOLL Circulation, Inc.	2	Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3
Z-0041-2022	ZOLL Circulation, Inc.	2	ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190
Z-0042-2022	ZOLL Circulation, Inc.	2	ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:
Z-0043-2022	ZOLL Circulation, Inc.	2	ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312
Z-0044-2022	ZOLL Circulation, Inc.	2	ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075510

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010617000. Last updated year: 2026. Please use registration number 3010617000 when referencing this establishment in official correspondence.