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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- HRXArthroscope2Product Code
- K242417VECTR – Video Endoscopic Carpal Tunnel Release System2Cleared 510(K)
- K243020MIDASVu2Cleared 510(K)
- K233800Vertos mild Device Kit (MDK-0002)2Cleared 510(K)
- K240535Digital ClarusScope System; Digital NeuroPEN System2Cleared 510(K)
- K233675FMS VUE™ Fluid Management and Tissue Debridement System2Cleared 510(K)
- K233115Hawkeye Control Unit with Eyas Endoscope2Cleared 510(K)
- K223709Kyphoplasty Balloon Catheter2Cleared 510(K)
- K221142Kyphoplasty Balloon System2Cleared 510(K)
- K221919DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets2Cleared 510(K)
- K223406SmartRelease Endoscopic Soft Tissue Release System2Cleared 510(K)
Show All 669 Submissions
- LZEIsometer1Product Code
- NBHAccessories, Arthroscopic1Product Code
- NGRTester, Stiffness, Cartilage, Arthroscopic2Product Code
- PPRSurgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures2Product Code
- QGQBone Indentation Device2Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K221919
- 510(k) Type
- Traditional
- Applicant
- Hemodia SAS
- Country
- France
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/9/2023
- Days to Decision
- 251 days
- Submission Type
- Summary