Maxima Forte Hollow Fiber Oxygenator with Plasma Resistant Fiber
FDA 510(k) K962641 · Medtronic Vascular
510(k) numberK962641
Submission
- Device name
- Maxima Forte Hollow Fiber Oxygenator with Plasma Resistant Fiber
- Applicant
- Medtronic Vascular
Anaheim, CA, US - Received
- July 5, 1996
- Decision date
- December 16, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTZ – Oxygenator, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4350
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum…DTZ · Traditional | Qura S.R.L | 11/08/2023SE |
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Questions and answers
When was Maxima Forte Hollow Fiber Oxygenator with Plasma Resistant Fiber cleared by the FDA?
Maxima Forte Hollow Fiber Oxygenator with Plasma Resistant Fiber (K962641) received a 510(k) decision of Substantially Equivalent on December 16, 1996, 164 days after the submission was received.
What is the product code of K962641?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.