Interflo Medical Model F-1 Thermodilution Catheter
FDA 510(k) K900710 · Intec Medical, Inc.
510(k) numberK900710
Submission
- Device name
- Interflo Medical Model F-1 Thermodilution Catheter
- Applicant
- Intec Medical, Inc.
Plano, TX, US - Received
- February 14, 1990
- Decision date
- October 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRB – Probe, Thermodilution
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1915
- Specialty
- Cardiovascular
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Questions and answers
When was Interflo Medical Model F-1 Thermodilution Catheter cleared by the FDA?
Interflo Medical Model F-1 Thermodilution Catheter (K900710) received a 510(k) decision of Substantially Equivalent on October 19, 1990, 247 days after the submission was received.
What is the product code of K900710?
The FDA product code is KRB – Probe, Thermodilution, a Class II (moderate risk) device regulated under 21 CFR 870.1915.