Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009437315

FEI Number

3009437315

Entity Name

CIRCA Scientific, Inc.

City/State/Country

Englewood, CO, US

Establishment Address

14 Inverness Dr E Ste H-136, Englewood, CO 80112, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

CIRCA Scientific, Inc. (Owner Number: 10038213)

Owner / Operator Contact Address

14 Inverness Drive East, Suite H-136, Englewood, CO 80112, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222311

PMA Number

N/A

All Registered Proprietary Names

CardioCurve Steerable Sheath CrossWise Multi-Use RF Adapter Cable S-CATH Esophageal Temperature Probe and Temperature Monitoring System CardioCurve Steerable Sheath PeriCross Epicardial Access Kit CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System CrossWise RF Transseptal Access System CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-05-03
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2024-11-27
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2011-09-23
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-08-01
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-06-13
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2022-01-18
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-01-18
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2024-10-29
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-06-20
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2023-06-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CIRCA Scientific, Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

Similar Registrations

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3017689643	CARDIOVIA Ltd.	Nazareth Northern, IL
3041086754	PULNOVO MEDICAL (WUXI) CO., LTD.	Wuxi Jiangsu, CN
3013764800	B. BRAUN MEDICAL INC.	Allentown, PA, US
2020394	BARD PERIPHERAL VASCULAR, INC.	TEMPE, AZ, US
3016904853	SAINT JONES MANAGEMENT LP EOOD	Sofia Sofia-Grad, BG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009437315. Last updated year: 2026. Please use registration number 3009437315 when referencing this establishment in official correspondence.