Anesthesiology
Review Panel
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- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
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- 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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Left Atrial Appendage Clip, Implantable
- Page Type
- Product Code
- Definition
- Intended to occlude the left atrial appendage.
- Physical State
- A clip-like device that compresses the left atrial appendage.
- Technical Method
- Epicardially applied during a concomitant surgical procedure to physically occlude the left atrial appendage.
- Target Area
- Left atrial appendage of the heart.
- Regulation Medical Specialty
- General and Plastic Surgery
- Review Panel
- Cardiovascular
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 878.4300
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- Yes
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 878.4300 Implantable clip
§ 878.4300 Implantable clip.
(a) Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.
(b) Classification. Class II.