Product code DQI— Cardiovascular

FDA has cleared 9 devices under product code DQI between 1987 and 1996, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19961 clearance
• 19941 clearance
• 19922 clearances
• 19911 clearance
• 19903 clearances
• 19871 clearance

• Baxter Healthcare Corp2 clearances
• W.O.M. World of Medicine GmbH1 clearance
• Olympus Corp.1 clearance
• Nobles-Lai Engineering, Inc.1 clearance
• Leocor, Inc.1 clearance
• Karl Storz Endoscopy1 clearance
• Intramed Laboratories, Inc.1 clearance
• C.R. Bard, Inc.1 clearance

• K960486 — KSEA MODEL 383320 20 ANGIOMATKarl Storz Endoscopy·1996-10-25
• K935763 — SURGIPUMPW.O.M. World of Medicine GmbH·1994-04-21
• K922541 — USCI SUPER 9 PTCA GUIDING CATHETERC.R. Bard, Inc.·1992-12-08
• K924110 — LEOCOR CORFLO PUMP -- MODIFICATIONLeocor, Inc.·1992-09-01
• K905189 — BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL)Baxter Healthcare Corp·1991-01-30
• K902444 — CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMPIntramed Laboratories, Inc.·1990-08-30
• K895688 — NOBLES-LAI ENGINEERING INFUSION PUMPNobles-Lai Engineering, Inc.·1990-02-26
• K895074 — ANGIOSCOPY PUMPBaxter Healthcare Corp·1990-01-31
• K871422 — OLYMPUS ANGIOSCOPY PUMPOlympus Corp.·1987-08-12