FDA Registration
Active
🇺🇸 United States
CIRCA Scientific, Inc.
Reg #: 3009437315
·
FEI: 3009437315
·
Expires 2026
Products
4
Proprietary Names
7
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- CIRCA Scientific, Inc.
- Registration Number
- 3009437315
- FEI Number
- 3009437315
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 14 Inverness Dr E Ste H-136
- City
- Englewood
- State
- CO
- ZIP
- 80112
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210185
Owner / Operator
- Firm Name
- CIRCA Scientific, Inc.
- Operator Number
- 10038213
- Address
- 14 Inverness Drive East, Suite H-136
- City
- Englewood
- State
- CO
- Postal Code
- 80112
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2023-05-03 |
| Catheter, Septostomy | DXF | Class 2 | Cardiovascular | No | 2024-11-27 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2011-09-23 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2022-01-18 |
Proprietary Names
CardioCurve Steerable Sheath
CrossWise Multi-Use RF Adapter Cable
S-CATH Esophageal Temperature Probe and Temperature Monitoring System
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
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device