CSA Medical

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3010140265	3010140265	CSA Medical	1	N	2026-01-01	131 Hartwell Ave Lexington MA US 02421

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00857068006020	truFreeze - Active Venting Catheter	1-866-481-7786	service@csamedical.com
00857068006037	truFreeze - Active Venting Cryo Decompression Tube	1-866-481-7786	service@csamedical.com

csamedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
159484	1165902809	K172041	truFreeze System	GEH	2017-07-27
159484	1350634208	K171626	truFreeze System	GEH	2017-08-30
159484	1092953902	K171522	truFreeze Rapid AV Spray Kit	GEH	2017-07-14
159484	1999881272	K163244	truFreeze System	GEH	2017-05-24
159484	1423254522	K162695	truFreeze System	GEH	2016-10-25
159484	1756866236	K161557	truFreeze System	GEH	2016-07-26
159484	1958579784	K160273	truFreeze System	GEH	2016-03-25
159484	1077095171	K152668	truFreeze System	GEH	2015-10-14
159484	1682218235	K150920	truFreeze System	GEH	2015-06-17
159484	1669575809	K143625	truFreeze System	GEH	2015-01-15
159484	1343352376	K133258	TRUFREEZE SYSTEM	GEH	2014-06-19
159484	1678732028	K113021	TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT	GEH	2012-02-07
159484	1693033419
159484	2063942200

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GEH	12	2017-08-30

PMN#

Vortex Radial Spray Catheter

2020-12-07

CSA Medical, Inc.

TruFreeze System

2017-08-30

CSA Medical, Inc.

TruFreeze System

2017-07-27

CSA Medical, Inc.

TruFreeze Rapid AV Spray Kit

2017-07-14

CSA Medical, Inc.

TruFreeze System

2017-05-24

CSA MEDICAL, INC.

TruFreeze System

2016-10-25

CSA MEDICAL, INC.

TruFreeze System

2016-07-26

CSA MEDICAL, INC.

TruFreeze System

2015-10-14

CSA MEDICAL, INC.

TruFreeze System

2015-06-17

CSA MEDICAL, INC.

TruFreeze System

2015-01-15

CSA MEDICAL, INC.

TRUFREEZE SYSTEM

2014-06-19

CSA MEDICAL, INC.

TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT

2012-02-07

CSA MEDICAL, INC.

CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM

2007-12-07

CSA MEDICAL, INC.

CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500

2007-05-01

CSA MEDICAL, INC.

GUDID#

truFreeze - Active Venting Catheter Qty 1

Csa Medical, Inc.

2017-10-05

truFreeze - Rapid AV Catheter

Csa Medical, Inc.

2017-09-26

truFreeze - Rapid Av Active Venting Spray Kit - 5 Rapid AV Catheters, 5 Active Venting 16 Fr LD CDT

Csa Medical, Inc.

2017-09-26

truFreeze - 16 Fr Active Venting Kit. 5 - 16 Fr Active Venting Cryo Decompression Tube (Low Durometer)5 - Active Venting Catheter

Csa Medical, Inc.

2017-10-05

truFreeze - 16 Fr. Active Venting Cryo Decompression Tube (Low Durometer)

Csa Medical, Inc.

2017-09-26

truFreeze - Active Venting Spray Kit5 Active Venting Cryo Decompression Tube5 Active Venting Catheter

Csa Medical, Inc.

2016-09-16

truFreeze - Active Venting Cryo Decompression Tube

Csa Medical, Inc.

2016-09-16

truFreeze - Active Venting Catheter

Csa Medical, Inc.

2016-09-16

truFreeze - Passive Venting Catheter

Csa Medical, Inc.

2016-09-16

truFreeze - truFreeze Console

Csa Medical, Inc.

2016-09-16

truFreeze - Rapid AV Kit with 20 Fr CDT (5 pack)

Csa Medical, Inc.

2019-07-15

truFreeze - Box of 5 Active Venting Catheters

Csa Medical, Inc.

2017-10-05

truFreeze - Rapid AV Catheter, box of 5

Csa Medical, Inc.

2017-09-26

truFreeze - Box of 5 Active Venting Cryo Decompression Tubes

Csa Medical, Inc.

2016-09-16

truFreeze - Box of 5 Active Venting Catheters

Csa Medical, Inc.

2016-09-16

truFreeze - Box of 5 Passive Venting Catheters

Csa Medical, Inc.

2016-09-16

truFreeze - 16 Fr Active Venting Cryo Decompression Tube (Low Durometer), Box of 5

Csa Medical, Inc.

2017-09-26

truFreeze - 16 Fr. Active Venting Kit 5 16 Fr. Active Venting Cryo Decompression Tube 5 Active Venting Catheter

Csa Medical, Inc.

2017-03-14

truFreeze - 16 Fr. Active Venting Cryo Decompression Tube

Csa Medical, Inc.

2017-03-14

truFreeze - 16 Fr. Active Venting Cryo Decompression Tube Box of 5

Csa Medical, Inc.

2017-03-14