Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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Apparatus, Autotransfusion
- Page Type
- Product Code
- Regulation Medical Specialty
- Anesthesiology
- Review Panel
- Cardiovascular
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 868.5830
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- Yes
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 868.5830 Autotransfusion apparatus
§ 868.5830 Autotransfusion apparatus.
(a) Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.
(b) Classification. Class II (performance standards).