510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Guidant Corporation, Cardiac Surgery

Santa Clara, CA, US

Guidant Corporation, Cardiac Surgery appears in FDA device records in Santa Clara, CA. FDA records list 8 510(k) clearances between and , no 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
8
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 8 510(k) clearances for Guidant Corporation, Cardiac Surgery between 2002 and 2008. The busiest year on record is 2002, with 4. The most recent is 2008, with 1.

Clearances by year, as a table
510(k) clearance decisions for Guidant Corporation, Cardiac Surgery, by decision year
YearClearances
20024
20032
20041
20081
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K080169HEARTSTRING III PROXIMAL SEAL SYSTEMDXCSubstantially Equivalent
K041340GUIDANT MICROWAVE ABLATION SYSTEMNEYSubstantially Equivalent
K023630ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400GCJSubstantially Equivalent
K024071GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEMNHWSubstantially Equivalent
K023629ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200GCJSubstantially Equivalent
K022718VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002GEISubstantially Equivalent
K020701SYNCRUS INTERNAL CARDIOVERSION SYSTEMNHWSubstantially Equivalent
K020143VASOVIEW 5 HARVESTING CANNULAHETSubstantially 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