Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- DWMApparatus, Suction, Patient Care2Product Code
- K212696Aspira Pleural Drainage System2Cleared 510(K)
- K210509Rocket Platinum Cured Cathter2Cleared 510(K)
- K201404Passio Pump Drainage System2Cleared 510(K)
- K190292Passio Pump Drainage System2Cleared 510(K)
- K163321Rocket Indwelling Pleural Catheter (IPC) Insertion Kit2Cleared 510(K)
- K160450Pleurx Pleural Catheter System2Cleared 510(K)
- K141965PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT2Cleared 510(K)
- K123033ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B2Cleared 510(K)
- K121849PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE2Cleared 510(K)
- K112831PLEURX PLEURAL CATHETER SYSTEMS2Cleared 510(K)
- K110409ASPIRA PLEURAL DRAINAGE SYSTEM2Cleared 510(K)
- K093307ASEPT PLEURAL DRAINAGE SYSTEM2Cleared 510(K)
- K071095ASPIRA PLEURAL DRAINAGE SYSTEM2Cleared 510(K)
- K052436PLEURX PLEURAL CATHETER KIT, MODEL 50-70002Cleared 510(K)
- K051084DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE2Cleared 510(K)
- K011831MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS2Cleared 510(K)
- K010642PLEURX PLEURAL CATHETER AND DRAINAGE KITS2Cleared 510(K)
- K971753DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-75002Cleared 510(K)
- K803037WILLIAM HARVEY VENTED MEDIASTINAL DRAIN2Cleared 510(K)
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—MiscellaneousCFR Sub-Part
- 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
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500
- Page Type
- Cleared 510(K)
- 510(k) Number
- K971753
- 510(k) Type
- Traditional
- Applicant
- DENVER BIOMATERIALS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent - Kit
- Decision Date
- 6/27/1997
- Days to Decision
- 46 days
- Submission Type
- Summary