Numed Balloon Thermodilution Catheter
FDA 510(k) K881893 · NuMED, Inc.
510(k) numberK881893
Submission
- Device name
- Numed Balloon Thermodilution Catheter
- Applicant
- NuMED, Inc.
Hopkinton, NY, US - Received
- May 5, 1988
- Decision date
- September 6, 1988
- 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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| K915627 | PaceviewKRB · Traditional | Micromedical Industries, Ltd. | 03/27/1992SE |
| K912172 | Safewedge(Tm) Relief Valve DeviceKRB · Traditional | Sunscope Intl., Inc. | 09/27/1991SE |
| K902627 | Interflo Medical Model Oxi/Co Fila. Thermo. Cath.KRB · Traditional | Biometric Research Institute, Inc. | 02/25/1991SE |
| K900710 | Interflo Medical Model F-1 Thermodilution CatheterKRB · Traditional | Intec Medical, Inc. | 10/19/1990SE |
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Questions and answers
When was Numed Balloon Thermodilution Catheter cleared by the FDA?
Numed Balloon Thermodilution Catheter (K881893) received a 510(k) decision of Substantially Equivalent on September 6, 1988, 124 days after the submission was received.
What is the product code of K881893?
The FDA product code is KRB – Probe, Thermodilution, a Class II (moderate risk) device regulated under 21 CFR 870.1915.