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)
- K955645CATH-GUIDE1Cleared 510(K)
- K952395REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION1Cleared 510(K)
- K952396REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION1Cleared 510(K)
- K953226PULM O2 SUCTION CATHETER TRAYS1Cleared 510(K)
- K951506SUCTION CATHETER KIT, STERILE, SINGLE-USE1Cleared 510(K)
- K945994DUAL PURPOSE CATHETER1Cleared 510(K)
- K951745CONNECTING TUBE1Cleared 510(K)
- K945950TRIGUARD(TM) SUCTION SYSTEM1Cleared 510(K)
- K944251KENDALL MODU-VAC CLOSED SUCTION SYSTEM1Cleared 510(K)
- K935600TRACHEAL SUCTION CATHETER1Cleared 510(K)
- K935583SUCTION SET, TRACHAEL1Cleared 510(K)
- K935553MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP1Cleared 510(K)
- K934723ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM1Cleared 510(K)
- K925556ARGYLE ASPIR-FLEX SUCTION CATHETER1Cleared 510(K)
- K9218514 SURE TM SUCTION CATHETERS & KITS1Cleared 510(K)
- K922843DYNAREX SUCTION CATHETERS & KITS1Cleared 510(K)
- K922148ARGYLE AERO-JET SUCTION CATHETER1Cleared 510(K)
- K923098STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE1Cleared 510(K)
- K903480HANN-VAC TM, DISPOSABLE,SUCTION CATHETER1Cleared 510(K)
- K912596MECONIUM ASPIRATION1Cleared 510(K)
- K910239NEBU-SOL METERED DOSE DISPENSER (TM)1Cleared 510(K)
- K910909MUCAID1Cleared 510(K)
- K910908MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING1Cleared 510(K)
- K903552ORAL-CATH SUCTION CATHETER1Cleared 510(K)
- K903740TRACH-EZE1Cleared 510(K)
- K902093RESU-GARD CATHETER SUCTION1Cleared 510(K)
- K903669GENESIS INSUFFLATING CATHETER1Cleared 510(K)
- K902687STERI-CATH-DL1Cleared 510(K)
- K902814SUCTION CATHETER, STERILE1Cleared 510(K)
- K902297BUSSE BAC/SHIELD1Cleared 510(K)
- K902383STERI-CATH(TM)1Cleared 510(K)
- K896887TRACHAEL SUCTION SET1Cleared 510(K)
- K896730SUCTION CATHETER STRAIGHT/COUDE1Cleared 510(K)
- K896797SUCTION CATHETER KIT1Cleared 510(K)
- K896560MUCOUS TRAP1Cleared 510(K)
- K896321NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.1Cleared 510(K)
- K894299REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM1Cleared 510(K)
- K892529REPRO-MED NEONATE ASPIRATION SYSTEM1Cleared 510(K)
- K893462NU-TRAP SUCTION CATHETER W/MUCUS TRAP1Cleared 510(K)
- K893204MUC-X1Cleared 510(K)
- K892441KENDALL CURITY SUCTION CATHETERS1Cleared 510(K)
- K892343SUCTION CONTROL VALVE1Cleared 510(K)
- K890425NEOTECH MUCUS TRAP W/CATHETER1Cleared 510(K)
- K884944TU SUCTIONTRAP1Cleared 510(K)
- K885131KIT PAK SUCTION CATHETER KIT1Cleared 510(K)
- K883384TS1000 SUCTION TIP1Cleared 510(K)
- K882017RESPIRONICS SUCTIONEASY1Cleared 510(K)
- K881428OXY-CATH1Cleared 510(K)
- K875058STERILE MUCUS SPECIMEN TRAP, MODELS 406 & 4071Cleared 510(K)
- K873810SAFETY SHIELD SUCTION CATHETER1Cleared 510(K)
- K873610PEDIATRIC BUBBLE TRAP CAT. NO. B-1001Cleared 510(K)
- K873732TRACH CARE START KIT1Cleared 510(K)
- K872621TRACH CARE CATHETER1Cleared 510(K)
- K872141CENTURION SPECIMEN TRAP W/CATHETER1Cleared 510(K)
- K872917JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER1Cleared 510(K)
- K872283ORAL SUCTION CATHETER1Cleared 510(K)
- K871825MECONIUM SUCTION CATHETER1Cleared 510(K)
- K871949MMG DELEE SUCTION CATHETER W/MUCOUS TRAP1Cleared 510(K)
- K871407MECONIUM ASPIRATOR1Cleared 510(K)
- K870962GESCO ASPIRATOR1Cleared 510(K)
- K864535TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 61101Cleared 510(K)
- K864468TRACHEOBRONCHIAL SUCTION CATHETER1Cleared 510(K)
- K861949SUCTION CATHETER KIT1Cleared 510(K)
- K863497SUCTION CATHETER KIT1Cleared 510(K)
- K862181MECONIUM SUCTION TRAP1Cleared 510(K)
- K862132HCI MECONIUM ASPIRATOR1Cleared 510(K)
- K860802TRACHEOBRONCHIAL SUCTION CATHETER1Cleared 510(K)
- K854320ACKRAD ORAL SUCTION TUBE1Cleared 510(K)
- K851473VYGON DELEE SUCTION CATHETER CODE NO 5331Cleared 510(K)
- K852080PENNINE SUCTION CATHETERS1Cleared 510(K)
- K852079PENNINE DERBY YANKAUER1Cleared 510(K)
- K850864TRACHEOBRONCHIAL SUCTION KITS W/CATHETERS ETO1Cleared 510(K)
- K850784BRONCHITRAC L1Cleared 510(K)
- K850105KM PRODUCTS ASPIRATING TUBING1Cleared 510(K)
- K842166INTERMED, INS STERILE WATER/SALINE1Cleared 510(K)
- K850032A FAMILY OF TRACHEOBRONCHIAL SUCTION CATHETER PROD1Cleared 510(K)
- K843797STERILE SALINE SOLUTION1Cleared 510(K)
- K843076SUCTION CATHETER KIT1Cleared 510(K)
- K842779ACT, SUCTION TIP1Cleared 510(K)
- K841425JINOTTI OXYGEN/SUCTION CATHETER1Cleared 510(K)
- K842198AMER. PHARMASEAL NO TOUCH SATIN CATHET1Cleared 510(K)
- K842205OXY-VAC1Cleared 510(K)
- K841480INFECTION CONTROL VALVE1Cleared 510(K)
- K840664TRACHEOSTOMY CLEANING TRAY1Cleared 510(K)
- K833375DUAL PURPOSE CATHETER1Cleared 510(K)
- K833908IRRI-CATH1Cleared 510(K)
- K833633BRONCHITRAC DF DUAL RESP/CATHETER1Cleared 510(K)
- K830709ARGYLE SUCTION CATHETERS1Cleared 510(K)
- K822724SUCTION TUBES1Cleared 510(K)
- K822398ACKRAD BRONCHITRAC1Cleared 510(K)
- K820369SUCTION CATHETERS & KITS1Cleared 510(K)
- K820109RADIATION STERILIZED SUCTION CATHETERS1Cleared 510(K)
- K813324BODAI SWIVEL Y1Cleared 510(K)
- K813163SUCTION CATHETER1Cleared 510(K)
- K813209TRACHEOBRONCHIAL SUCTION CATHETER1Cleared 510(K)
- K812747ARGYLE SUCTION CATHETERS1Cleared 510(K)
- K811542MGN SUCTION CATHETER1Cleared 510(K)
- K811241BODAI SUCTION -SAFE 41Cleared 510(K)
- K810023HYDROPHILIC COATED CATHETER1Cleared 510(K)
- K801814CATHETER SUCTION TRACHEOBRONCHIAL1Cleared 510(K)
- K801551ARGYLE SAF-T-MARK SUCTION CATHETER1Cleared 510(K)
- K800503SUCTION CATHETER1Cleared 510(K)
- K791253CONPHAR SUCTION CATHETER-W/0 CONTROL1Cleared 510(K)
- K790606CATHETERS, GREENLINE SUCTION1Cleared 510(K)
- K760427CATHETER, DOVER SUCTION W/ GLOVE1Cleared 510(K)
- K760371VENT-O2-CATH1Cleared 510(K)
- 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
- 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
BODAI SWIVEL Y
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K813324
- 510(k) Type
- Traditional
- Applicant
- SONTEK INDUSTRIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/29/1981
- Days to Decision
- 35 days