Anesthesiology
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- 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
- OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue2Product Code
- PAWNonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement2Product Code
- PZXLeft Atrial Appendage Clip, Implantable2Product Code
- SFQElectrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision2Product Code
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision
- Page Type
- Product Code
- Definition
- Surgical device used to dissect cardiac tissue for the implantation and revision of cardiac electrophysiology leads
- Physical State
- Electrocautery system and accessories with radiofrequency generator and probe
- Technical Method
- Delivers radiofrequency energy through a probe to cut and coagulate targeted cardiac tissue
- Target Area
- Cardiac tissue where electrophysiology implants will be placed
- Regulation Medical Specialty
- General and Plastic Surgery
- Review Panel
- Cardiovascular
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 878.4400
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
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CFR § 878.4400 Electrosurgical cutting and coagulation device and accessories
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a) Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
(b) Classification. Class II.