Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005748481

FEI Number

3005748481

Entity Name

ICAT S.A. DE C.V.

City/State/Country

San Salvador, SV

Establishment Address

KM 12.5 Carretera Troncal del Norte, Apopa, San Salvador n/a, SV

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ICAT S.A. de C.V. (Owner Number: 10040106)

Owner / Operator Contact Address

KM 12.5 Carretera Troncal del Norte, Apopa, San Salvador, SV-SS 00000, SV

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STC ID Code NG1 ComPel Surgical Gowns PB70 STC ID Code NH9 Perval Surg Gowns & Generic Poly Surg Gowns George Courey Inc STC ID Product Codes AB1, AB Non Surgical Gowns and Cover Gowns STC ID Code NG 1 ComPel Surgical OR Gowns Encompass Encompass Group LLC STC ID Code NA1 NA3 NB1 NB3 ComPel Surgical Drapes STC ID Product Codes CAA, CAO, CA1 - CA10, MD1, SZ1 Underpads, Drawsheets, Mattress Covers George Courey Inc STC ID Code ND1 ND2 Wrappel Wrappers Barrier Supreme Drapes and Standard Supreme Drapes STC ID Code NG3 NG5 ComPel XTR Surg Gowns Barrier Supreme Sterilization Wrapper STC ID Code NE1 NE2 NE3 NE4 NE5 NE7 OR Towels Toughweave, Sofsorb, Absorbent, Namewoven, Perval, & EStar STC ID Product Codes AG8 Examination Apparel and Xray Gowns MEDLINE INDUSTRIES, LP - Northfield

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-11-06
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-11-06
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-09-18
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-04-21
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2012-03-08
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2012-03-08
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-04-21
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-11-06
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2013-07-15
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2025-04-21
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2013-09-12
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-04-21
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2015-11-06
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2013-03-14
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-04-21
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-09-18
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2015-11-06
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2013-01-24
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2020-01-02
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2012-03-08
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-11-06
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-04-09
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2015-11-06
FME	Gown, Examination	General Hospital	Class 1	880.6265	2012-03-08
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2025-11-21

Official Correspondent

Miguel Sandoval

US Agent Details

Tim Wirring Email: twirrig@standardtextile.com Phone: (513) 7619255

Related Public Records

Same Entity

ICAT S.A. de C.V.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011497662	Vidales Larranaga SA de CV	Ahuachapan, SV

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19

Similar Registrations

Registration Number	Establishment Name	Location
3042245424	Sino Protection Holding Co Limited Egypt Branch Ismailia Free Zone	Ismailia Al Isma'iliyah, EG
3016678045	Schneider ASR B.V.	Rotterdam-Albrandswaard Zuid-Holland, NL
8030672	Cirpro de Delicias S. de R.L. de C.V.	DELICIAS Chihuahua, MX
1527607	SRI Healthcare, LLC	MASON, OH, US
3027977504	MEDLINE CHILE SPA	Pudahuel Region Metropolitana, CL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005748481. Last updated year: 2026. Please use registration number 3005748481 when referencing this establishment in official correspondence.