Pressure Relief Valve
FDA 510(k) K941492 · Circulatory Technology, Inc.
510(k) numberK941492
Submission
- Device name
- Pressure Relief Valve
- Applicant
- Circulatory Technology, Inc.
Oyster Bay, NY, US - Received
- March 28, 1994
- Decision date
- October 26, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K992964 | Ibc Vent Valve, Model 1400MNJ · Traditional | International Biophysics Corp. | 11/19/1999SE |
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| K964205 | Better-TubingDWF · Traditional | 04/08/1998SE |
| K964337 | Better-Bladder (BB)FIB · Traditional | 05/23/1997SE |
| K961594 | Better-VenterDWF · Traditional | 09/05/1996SE |
| K942933 | Pressure Infusion CuffKZD · Traditional | 08/25/1994SE |
Questions and answers
When was Pressure Relief Valve cleared by the FDA?
Pressure Relief Valve (K941492) received a 510(k) decision of Substantially Equivalent on October 26, 1994, 212 days after the submission was received.
What is the product code of K941492?
The FDA product code is MNJ – Valve, Pressure Relief, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.