510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Strato Medical Corp.

Mchenry, IL, US

Strato Medical Corp. appears in FDA device records in Mchenry, IL. FDA records list 45 510(k) clearances between and , 3 PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
45
PMA records
3
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 45 510(k) clearances for Strato Medical Corp. between 1984 and 1995. The busiest year on record is 1991, with 18. The most recent is 1995, with 4.

Clearances by year, as a table
510(k) clearance decisions for Strato Medical Corp., by decision year
YearClearances
19841
19852
19862
19874
19882
19892
19902
199118
19921
19936
19941
19954
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K945956STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMSLJSSubstantially Equivalent
K946250STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMSLJSUnknown
K942848STRATO MEDICAL LIFEPORT LPS 7515LJTSubstantially Equivalent
K934518STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEMLJTUnknown
K932509STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORTLJTSubstantially Equivalent
K933884STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEMLJSUnknown
K924851STRATO MEDICAL SINGLE LUMEN VALVED CATHETERLJSUnknown
K924677STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATHLJSUnknown
K921751INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETERLJSUnknown
K915273LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555LJTUnknown
K924505SNAP-LOCK MICROPORT - REVISEDLJTSubstantially Equivalent
K921674LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITEFPASubstantially Equivalent
K911782PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEMFRNSubstantially Equivalent
K905852STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIEDLJTUnknown
K905850STRATO PLASTIC PORT INTRO(9 FR)LPS 7513/MODIFIEDLJTUnknown
K905849STRATO PLASTIC PORT INTRO KT(10 FR) LPS 7523/MODIFLJTUnknown
K905845STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIEDLJTUnknown
K905843STRATO PLAST INTRODUCER KIT(12 FR) LPS 7113/MODIFLJTUnknown
K905842STRATO PORT INTRODUCER KT(12 FR) LPS 5213/MODIFIEDLJTUnknown
K905841STRATO PORT INTRODUCER KT(12 FR) LPS 5200/MODIFIEDLJTUnknown
K905840STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIEDLJTUnknown
K905839STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIEDLJTUnknown
K905838STRATO PORT INTRODUCER KT(10 FR) LPS 5015/MODIFIEDLJTUnknown
K911355LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015LJTSubstantially Equivalent
K905848LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODILJTSubstantially Equivalent
K905846STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATIONLJTSubstantially Equivalent
K905851STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIEDLJTSubstantially Equivalent
K905847STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATIONLJTSubstantially Equivalent
K905844STRATO STAND METAL PORTS (LPS 1013/1015)/MODIFIEDLJTSubstantially Equivalent
K905696STRATOFUSE PCA INFUSERFRNSubstantially Equivalent
K895543WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS CATHETERLJSSubstantially Equivalent
K896598STRATO INDWELLING CATHETERLJSSubstantially Equivalent
K895689LIFEPORT VASCULAR ACCESS PORTLJTSubstantially Equivalent
K895871LIFEPORT POLYURETHANE CATHETERLJTSubstantially Equivalent
K881075LIFEPORT II, MODEL LPS-1100LJTSubstantially Equivalent
K880305LIFEPORT LOW PROFILE VASCULAR ACCESS PORT W/CATH.LJTSubstantially Equivalent
K870886LIFEPORT VASCULAR ACCESS SYSTEM W/0.76 MM CATHETERLJTSubstantially Equivalent
K870582LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITEFPASubstantially Equivalent
K870581LIFEPORT(R) 7 INCH CONTINUOUS INFUSION SETFPASubstantially Equivalent
K864808STRATO(R) PCA INFUSERFRNSubstantially Equivalent
K853827LIFE-PORT IMPLANTABLE VASCULAR ACCESSLJTSubstantially Equivalent
K854318LIFEPORT AMBULATORY INFUSION PUMPFRNSubstantially Equivalent
K850488STRATOFUSE SYRINGE PIGGYBACK PUMP 1030FRNSubstantially Equivalent
K844627STRATOFUSE SYRINGE PIGGYBACK PUMPFRNSubstantially Equivalent
K843249T-TYPE IV EXTENSION SETFPASubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain