Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- CACApparatus, Autotransfusion2Product Code
- K241236XTRA Collection sets; XTRA Sequestration set X2Cleared 510(K)
- K240426Aventus Clot Management System2Cleared 510(K)
- K240584XTRA Autotransfusion System (with XTRA Bowl sets)2Cleared 510(K)
- K231782FlowSaver Blood Return System (80-101)2Cleared 510(K)
- K221483FlowSaver Blood Return System2Cleared 510(K)
- K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)2Cleared 510(K)
- K201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain2Cleared 510(K)
- K210862Hemafuse System2Cleared 510(K)
- K210176FlowSaver Blood Filter2Cleared 510(K)
- K210089CATSmart, Automated Blood Processing Autotransfusion System2Cleared 510(K)
Show All 195 Submissions
- OEVCardiopulmonary Resuscitation Aid Kit2Product Code
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Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K201305
- 510(k) Type
- Traditional
- Applicant
- Atrium Medical Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/3/2021
- Days to Decision
- 476 days
- Submission Type
- Summary