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

Withdrawal/Infusion Pump

21 CFR 870.1800 / Cardiovascular
FDA source (opens on fda.gov)

DQI is the FDA product code for Withdrawal/Infusion Pump, a class II device type, regulated under 21 CFR 870.1800. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DQI
Device name
Withdrawal/Infusion Pump
Regulation
21 CFR 870.1800
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
9
Ingested recalls
0

Clearances, product code DQI

By decision year
9 clearances under product code DQI with a decision year between 1987 and 1996, 1990 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DQI by decision year
YearClearances
19871
19903
19911
19922
19941
19961

Applicants with the most clearances

Product code DQI
Applicants holding the most 510(k) clearances under product code DQI
ApplicantClearances
Baxter Healthcare Corporation2
C.R. Bard Inc1
Intramed Laboratories, Inc.1
Karl Storz Endoscopy-America, Inc.1
Leocor, Inc.1
Nobles-Lai Engineering, Inc.1
Olympus Corp.1
Novanta Medical GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code