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
- 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
- BRXStool, Anesthesia1Product Code
- BRYCabinet, Table And Tray, Anesthesia1Product Code
- BSYCatheters, Suction, Tracheobronchial1Product Code
- K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM1Cleared 510(K)
- K992902AMBU HAND POWER SUCTION PUMP1Cleared 510(K)
- K982945DUAL PURPOSE CLOSED CATHETER1Cleared 510(K)
- K981910SUCTION CATHETER1Cleared 510(K)
- K972258HI-CARE CLOSED SUCTION SYSTEM1Cleared 510(K)
- K973199AMSINO SUCTION CATHETER1Cleared 510(K)
- K961707TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM1Cleared 510(K)
- K964369TRACH CARE SET WITH MICROBAN1Cleared 510(K)
- K960488NEO 2 LINE SUCTION SYSTEM1Cleared 510(K)
- K955831ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM1Cleared 510(K)
Show All 116 Submissions
- BTICompressor, Air, Portable2Product Code
- BXJClip, Nose1Product Code
- BXKGas, Calibration (Specified Concentration)1Product Code
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)1Product Code
- CAMYoke Assembly, Medical Gas1Product Code
- CCXSupport, Patient Position1Product Code
- OFOAirway Suction Kit1Product Code
- OFRTracheobronchial Suction Catheter Kit1Product Code
- OFSTracheal Suction Set1Product Code
- OYINon-Bronchoscopic Bronchoalveolar Lavage Catheter1Product Code
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HI-CARE CLOSED SUCTION SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K972258
- 510(k) Type
- Traditional
- Applicant
- MALLINCKRODT MEDICAL
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/29/1997
- Days to Decision
- 195 days
- Submission Type
- Statement