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
- K050654AMSINO I.V. START KIT2Cleared 510(K)
- K001879INFUSION IV SET2Cleared 510(K)
- K963722IV START KIT2Cleared 510(K)
- K951167EMS I.V. START KIT2Cleared 510(K)
- K950184B. BRAUN IV START KITS2Cleared 510(K)
- K944041PERSONAL HEARING SYSTEM2Cleared 510(K)
- K943941SAFESTART VASCULAR ACCESS START KIT2Cleared 510(K)
- K935684IV START KIT2Cleared 510(K)
- K942238I.V. STARTPAK VASCULAR ACCESS START KIT2Cleared 510(K)
- K941469IV START KIT2Cleared 510(K)
- K925017IV PREP KIT (NON-STERILE)2Cleared 510(K)
- K925018IV PREP KIT W/O DRESSING (NON-STERILE)2Cleared 510(K)
- K933041COLD CD ASP MODULE, ITE2Cleared 510(K)
- K930196CEPTI-SEAL I.V. PREP KIT2Cleared 510(K)
- K924538IV START KIT2Cleared 510(K)
- K923361I.V. START KIT, STERILE, DISPOSABLE2Cleared 510(K)
- K924811I.V. START KIT2Cleared 510(K)
- K926031PRO-PREP I.V. START/SCRUB-PREP/BLOOD CULTURE KIT2Cleared 510(K)
- K922533IV START KIT CUSTOM SMP # A-Z2Cleared 510(K)
- K914475IV START KIT2Cleared 510(K)
- K875315I.V. START KITS2Cleared 510(K)
- K871731TELSTAR PREWIRE SERIES2Cleared 510(K)
- K871281IV START KIT2Cleared 510(K)
- K863796CREATIVE CARE SYSTEMS' IV START KIT2Cleared 510(K)
- K863712I.V. START KIT, STERILE, DISPOSABLES2Cleared 510(K)
- K852375I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVE2Cleared 510(K)
- K844614IV START KIT2Cleared 510(K)
- K842898CURITY I.V. START KIT2Cleared 510(K)
- K820490IV START TRAY2Cleared 510(K)
- K760876ARGYLE IV STARTER KIT (W/O DRUG)2Cleared 510(K)
- MCYWound Dressing Kit2Product Code
- 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
IV PREP KIT (NON-STERILE)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K925017
- 510(k) Type
- Traditional
- Applicant
- CUSTOMED, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/27/1993
- Days to Decision
- 337 days
- Submission Type
- Statement