Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- FPXStrip, Adhesive, Closure, Skin1Product Code
- FPYSheet, Burn1Product Code
- KGXTape And Bandage, Adhesive1Product Code
- KMFBandage, Liquid1Product Code
- LRSI.V. Start Kit2Product Code
- MCYWound Dressing Kit2Product Code
- K970721DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM2Cleared 510(K)
- K963719CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY2Cleared 510(K)
- K960585WOUND CARE COMPRESSION SYSTEM (WCCS)2Cleared 510(K)
- K952334DRESSING CHANGE TRAY2Cleared 510(K)
- K951021CIRCULON SYSTEM STEP 22Cleared 510(K)
- K951022CIRCULON SYSTEM STEP 12Cleared 510(K)
- K951476E-PACK PROCEDURE KITS2Cleared 510(K)
- K931932DRESSING CHANGE TRAY-MODIFIED2Cleared 510(K)
- K924690VARIOUS NON-STERILE CUSTOM TRAYS/KITS2Cleared 510(K)
- K923905WOUND DRESSING KIT2Cleared 510(K)
- K926063PER-Q-CATH DRESSING CHANGE TRAY2Cleared 510(K)
- K925021TPN TRAY (STERILE)2Cleared 510(K)
- K921347CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER2Cleared 510(K)
- K913480WOUND CARE TRAY A2Cleared 510(K)
- K912116PRESSURE SORE MANAGEMENT KIT2Cleared 510(K)
- K912684HOME MEDICAL KIT - FOR LITTLE HURTS2Cleared 510(K)
- K913479WOUND CARE TRAY B2Cleared 510(K)
- K912232ULCERCARE2Cleared 510(K)
- K912117LACERATION TRAY2Cleared 510(K)
- K910363MEGA DRESSING CHANGE KIT2Cleared 510(K)
- K910011POST SURGICAL KIT/POST BIOPSY KIT2Cleared 510(K)
- K905123G-TUBE DRESSING CHANGE TRAY2Cleared 510(K)
- K905572EDLICH WOUND MANAGEMENT TRAY2Cleared 510(K)
- K902811ROUTINE DRESSING TRAY2Cleared 510(K)
- MHWDressing, Compression1Product Code
- NECBandage, Liquid, Skin Protectant1Product Code
- OXQDressing Change Tray1Product Code
- PYOTape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use1Product Code
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K921347
- 510(k) Type
- Traditional
- Applicant
- MEDI-FLEX HOSPITAL PRODUCTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent - Kit with Drugs
- Decision Date
- 1/8/1993
- Days to Decision
- 296 days
- Submission Type
- Statement