ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE
Device Facts
| Record ID | K862549 |
|---|---|
| Device Name | ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE |
| Applicant | American Bentley |
| Product Code | KRI · Cardiovascular |
| Decision Date | Jul 15, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4200 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Cardiopulmonary bypass accessory equipment is a device that has no contact with blood and that is used in the cardiopulmonary bypass circuit to support, adjoin, or connect components, or to aid in the setup of the extracorporeal line, e.g., an oxygenator mounting bracket or system-priming equipment.
Special Controls
*Classification.* (1) Class I. The device is classified as class I if it does not involve an electrical connection to the patient. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 870.9.(2) Class II (special controls). The device is classified as class II if it involves an electrical connection to the patient. The special controls are as follows: (i) The performance standard under part 898 of this chapter, and (ii) The guidance document entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 870.9.
