510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Cardiovascular Imaging Systems, Inc.

Sunnyvale, CA, US

Cardiovascular Imaging Systems, Inc. appears in FDA device records in Sunnyvale, CA. FDA records list 19 510(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
19
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 19 510(k) clearances for Cardiovascular Imaging Systems, Inc. between 1989 and 1997. The busiest year on record is 1992, with 5. The most recent is 1997, with 1.

Clearances by year, as a table
510(k) clearance decisions for Cardiovascular Imaging Systems, Inc., by decision year
YearClearances
19892
19903
19913
19925
19934
19941
19971
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K970049BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/ITXSubstantially Equivalent
K942231MICROVIEW II/MICRORAIL II CATHETERSDQOSubstantially Equivalent
K933517AUTOMATIC PULL BACK DEVICEDQXSubstantially Equivalent
K930232CVIS INSIGHT IMAGING GUIDE CATHETERDQOSubstantially Equivalent
K924922CVIS INSIGHT IMAGING CATHETERDQOSubstantially Equivalent
K930311CVIS LONGVIEWDQOSubstantially Equivalent
K921879CBIS CATHETER PULL-BACK DEVICEDQOSubstantially Equivalent
K921750CVIS INSIGHT III SYSTEMITXSubstantially Equivalent
K921631CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINALITXSubstantially Equivalent
K921148CVIS INSIGHT CATHETERS FOR INTRACARDIAC USEITXSubstantially Equivalent
K921147CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USEITXSubstantially Equivalent
K911414CVIS INSIGHT IMAGING CATHETERSITXSubstantially Equivalent
K904618CVIS INSIGHT IMAGING CATHETERDQOSubstantially Equivalent
K905625CVIS INSIGHT IMAGING CATHETERDQOSubstantially Equivalent
K901562CVIS INSIGHT IMAGING CATHETERDXKSubstantially Equivalent
K901691CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USEDQOSubstantially Equivalent
K897153CVIS INSIGHT IMAGING CATHETERLYKSubstantially Equivalent
K893837CVIS ULTRA-SCAN ONE IMAGING CATHETERIYOSubstantially Equivalent
K891386CVIS ULTRA-SCAN ONE IMAGING SYSTEMIYOSubstantially 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