Ibc Vent Valve, Model 1400
FDA 510(k) K992964 · International Biophysics Corp.
510(k) numberK992964
Submission
- Device name
- Ibc Vent Valve, Model 1400
- Applicant
- International Biophysics Corp.
Austin, TX, US - Received
- September 2, 1999
- Decision date
- November 19, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNJ – Valve, Pressure Relief, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4400
- Specialty
- Cardiovascular
Other 510(k)s with product code MNJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K941492 | Pressure Relief ValveMNJ · Traditional | Circulatory Technology, Inc. | 10/26/1994SE |
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Questions and answers
When was Ibc Vent Valve, Model 1400 cleared by the FDA?
Ibc Vent Valve, Model 1400 (K992964) received a 510(k) decision of Substantially Equivalent on November 19, 1999, 78 days after the submission was received.
What is the product code of K992964?
The FDA product code is MNJ – Valve, Pressure Relief, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.