Chest Drainage Kit
The Chest Drainage Kit is a Class 2 general hospital convenience kit containing components for chest drainage procedures. It is under enforcement discretion per the FDA's May 20, 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) premarket notification to market; notably, it is GMP-exempt. The product code is PAD, with regulation number 880.6740 under the General Hospital medical specialty.
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Basic Information
- Product Code
- PAD
- Device Class
- FDA class 2
- Regulation Number
- 880.6740
- 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 22 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.