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

San Diego, CA, US

Y appears in FDA device records in San Diego, CA. FDA records list 44 510(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
44
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 44 510(k) clearances for Y between 1985 and 1996. The busiest year on record is 1988, with 7. The most recent is 1996, with 2.

Clearances by year, as a table
510(k) clearance decisions for Y, by decision year
YearClearances
19855
19865
19876
19887
19894
19903
19921
19937
19943
19951
19962
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K955846MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETERFLLSubstantially Equivalent
K960280IVAC NEEDLE FREE VALVE ADMINISTRATION SETSFPASubstantially Equivalent
K953225IVAC BALL VALCE ADMIN. SETSFPASubstantially Equivalent
K934095IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETSFPASubstantially Equivalent
K940897IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SETFPASubstantially Equivalent
K931550EZ ADMINISTRATION SETFPASubstantially Equivalent
K932544IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599FRNSubstantially Equivalent
K931549MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMPFRNSubstantially Equivalent
K922115IVAC NEEDLELESS INJECTION VALVEFPASubstantially Equivalent
K930781INFUSION PUMPFRNSubstantially Equivalent
K925228IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VALFPASubstantially Equivalent
K925091IVAC SYRING PUMP MODEL 770FRNSubstantially Equivalent
K923981IVAC SYRINGE PUMP - 740 SERIESFRNSubstantially Equivalent
K915063IVAC PC ANIFUSERMEASubstantially Equivalent
K901550IVAC(R) SYRINGE PUMP - MODEL 770FRNSubstantially Equivalent
K903879IVAC(R) SYRINGE PUMP - MODEL 740FRNSubstantially Equivalent
K896914IVAC MODEL 2090 INFRA RED THERMOMETERFLLSubstantially Equivalent
K894487IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+LDRSubstantially Equivalent
K894037IVAC(R) SPACE.SAVER(TM) VOLUMETRIC PUMP MODEL 599FRNSubstantially Equivalent
K891583IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIESFRNSubstantially Equivalent
K883986CRIS ADAPTERFPASubstantially Equivalent
K884307IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262LDRSubstantially Equivalent
K882302IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080FPASubstantially Equivalent
K875332IVAC VOLUMETRIC PUMP - MODEL 590FRNSubstantially Equivalent
K874481IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290LDRSubstantially Equivalent
K874491IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+LDRSubstantially Equivalent
K874581IVAC(R) DUAL RATE ADAPTER - MODEL 70090FPASubstantially Equivalent
K873884IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMPFRNSubstantially Equivalent
K873938IVAC(R) DUAL RATE SET - MODEL C50066FRNSubstantially Equivalent
K873776IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580+FRNSubstantially Equivalent
K872764IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053FRNSubstantially Equivalent
K870317IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280LDRSubstantially Equivalent
K864809IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580FRNSubstantially Equivalent
K870132IVAC FLOW CONTROL ADMINISTRATION SETLDRSubstantially Equivalent
K864164CRIS ADAPTED WITH VOLUME LIMITING BAGFPASubstantially Equivalent
K853664HEPARIN MICRO-INFUSORFRNSubstantially Equivalent
K852168ELECTRONIC COMMUNICATION SYS ACCESSORY FOR GRAVITYFRNSubstantially Equivalent
K860436IVAC MODEL 2080 ELECTRONIC THERMOMETERFLLSubstantially Equivalent
K854574IVAC CONTROLLED RELEASE INFUSION SYSTEMFPASubstantially Equivalent
K852488CONTROLLED RELEASE INFUSION SYSTEM(CRIS)FPASubstantially Equivalent
K851447IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMPFRNSubstantially Equivalent
K844843IVAC DRUG ADMINISTRATION DEVICEFPASubstantially Equivalent
K850182IVAC KEOFEED II POLYURETHANE FEEDING TUBEKNTSubstantially Equivalent
K844937IVAC 52-99-0 UNVENTED & 52-99-1 VENTED VOL. INFUSIFPASubstantially 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