Peripheral Catheter Insertion Kit
The Peripheral Catheter Insertion Kit is a convenience kit consisting of components used for the insertion of a peripheral catheter. It is classified as Class 2 (FDA Class 2) under regulation 880.5200 but is under FDA enforcement discretion per the May 20, 1997 Convenience Kits Interim Regulatory Guidance, meaning it does not require a 510(k) premarket notification to market. The product code is OWL under the General Hospital medical specialty.
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Basic Information
- Product Code
- OWL
- Device Class
- FDA class 2
- Regulation Number
- 880.5200
- 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 www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
FEI Numbers
This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.