Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—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)
Show All 19 Submissions
- 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
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- HematologyReview Panel
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- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
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- General and Plastic SurgeryReview Panel
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- UnknownReview Panel
Pleurx Pleural Catheter System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K160450
- 510(k) Type
- Traditional
- Applicant
- CAREFUSION
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/31/2016
- Days to Decision
- 256 days
- Submission Type
- Summary