Cardiopulmonary Bypass Catheter Kit
The Cardiopulmonary Bypass Catheter Kit (product code OEU) is a cardiovascular convenience kit containing catheters and related components used to establish and maintain cardiopulmonary bypass during open-heart surgery. Established under the May 1997 FDA Convenience Kits Interim Regulatory Guidance, it is under enforcement discretion and does not require a 510(k) submission if all guidance criteria are met. This device is FDA Class 2 under regulation 870.4210 in the Cardiovascular specialty. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OEU
- Device Class
- FDA class 2
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.