Chemo Priming Pin(Tm)

FDA 510(k) K914924 · Block Medical, Inc.

Substantially Equivalent

510(k) numberK914924

Submission

Device name
Chemo Priming Pin(Tm)
Applicant
Block Medical, Inc.
Carlsbad, CA, US
Received
November 4, 1991
Decision date
March 6, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FPA – Set, Administration, Intravascular
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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More from B.Braun Medical, Inc.

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K944692C-Series HomepumpFPA · Traditional 05/02/1995SE
K940117MID-500MEB · Traditional 06/10/1994ST
K934551Verifuse Ambulatory PumpMEA · Traditional 03/17/1994SE
K935236Flow Controlling Extension SetLDR · Traditional 02/24/1994SE
K932740Homepump NSFMED · Traditional 10/06/1993SE
K904663Auto Sash (TM)FPA · Traditional 11/23/1992SE
K914855Multiple Dose ControllerFRN · Traditional 01/24/1992SE
K914854ThumperFRN · Traditional 01/24/1992SE
K910695Auto Sash (TM)FPA · Traditional 03/21/1991SE
K902891Verifuse Ambulatory PumpFRN · Traditional 11/21/1990SE

Questions and answers

When was Chemo Priming Pin(Tm) cleared by the FDA?

Chemo Priming Pin(Tm) (K914924) received a 510(k) decision of Substantially Equivalent on March 6, 1992, 123 days after the submission was received.

What is the product code of K914924?

The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.