Catheter Repair Kit
The Catheter Repair Kit is a general hospital convenience kit containing the materials and tools needed to repair damaged or malfunctioning catheters, such as long-term indwelling catheters used for dialysis, urinary drainage, or vascular access, extending catheter usable life and avoiding replacement procedures. Product code PWR is established as a convenience kit under FDA's 1997 Convenience Kits Interim Regulatory Guidance and is under enforcement discretion, not requiring a 510(k) if all guidance criteria are met. Under regulation 21 CFR 880.5970, it is a Class II device subject to general and special controls. It falls under the General Hospital medical specialty and is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PWR
- Device Class
- FDA class 2
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Review Panel
- HO
- 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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.