Reservoir, Blood, Cardiopulmonary Bypass, Exempt
The Reservoir, Blood, Cardiopulmonary Bypass (Exempt) is a cardiovascular device used to temporarily store blood during cardiopulmonary bypass surgery, allowing the surgical team to maintain circulation while the heart is stopped. Product code PTN is the Class II exempt counterpart of DTN, exempted from the 510(k) premarket notification requirement under the 21st Century Cures Act, subject to the limitations in 21 CFR 870.9. Under regulation 21 CFR 870.4400, it is a Class II device requiring general and special controls but not a 510(k) if within exemption limits. It falls under the Cardiovascular medical specialty and is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PTN
- Device Class
- FDA class 2
- Regulation Number
- 870.4400
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
Definition
This product code is the class II exempt counterpart of DTN, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.