# K961107: B. Braun Guidewires

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Oct 1, 1996 after 195 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K852123 (1985). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852123: Wholey HI-Torque Guide Wires, Advanced Cardiovascular Systems, Inc. (1985) Summary page 1.
- K852354: Wholey HI-Torque Guide Wires, Advanced Cardiovascular Systems, Inc. (1985) Summary page 1.
- K854830: Acs HI-Torque Tapered Diameter Guide Wires, Advanced Cardiovascular Systems, Inc. (1986) Summary page 1.
- K861574: Acs HI-Torque Tapered Diameter Guide Wire, Advanced Cardiovascular Systems, Inc. (1986) Summary page 1.
- K861765: Acs Wholey HI-Torque Guide Wire, Advanced Cardiovascular Systems, Inc. (1986) Summary page 1.
- K862360: Acs HI-Torque Flex-T Guide Wire, Advanced Cardiovascular Systems, Inc. (1986) Summary page 1.
- K864585: Acs HI-Torque Floppy Guide Wire, 0.018 Inch, Advanced Cardiovascular Systems, Inc. (1986)
- K872220: Acs HI-Torque Flex-T Guide Wire (Modification), Advanced Cardiovascular Systems, Inc. (1987) Summary page 1.
- K874202: Acs HI-Torque Guide Wires, Advanced Cardiovascular Systems, Inc. (1988) Summary page 1.
- K874776: Acs 0.025-in HI-Torq Modif J/Stand Telesc Guidewir, Advanced Cardiovascular Systems, Inc. (1988) Summary page 1.
- K881787: Acs HI-Torque Standard & Intermedi. Guide Wire, Advanced Cardiovascular Systems, Inc. (1988) Summary page 1.
- K881897: Acs HI-Torque Floppy/Floppy II/Inter./Standard GW, Advanced Cardiovascular Systems, Inc. (1988) Summary page 1.
- K884262: Acs (R) HI-Torque Gold (TM) Guide Wire, Advanced Cardiovascular Systems, Inc. (1988) Summary page 1.
- K884895: Acs 0.010 HI-Torque Floppy Gold Guide Wire, Advanced Cardiovascular Systems, Inc. (1989) Summary page 1.
- K902755: .018 HI-Torque Floppy Guide Wire W/ Preshaped Tip, Advanced Cardiovascular Systems, Inc. (1990) Summary page 1.
- K905502: .010 HI-Torque Floppy Guide Wire W/Preshaped Tip, Advanced Cardiovascular Systems, Inc. (1991) Summary page 1.
- K913328: .010 HI-Torque Plus (TM) Guide Wire, Advanced Cardiovascular Systems, Inc. (1991) Summary page 1.
- K913631: .014 HI-Torque Floppy Pathfinder Guide Wire, Advanced Cardiovascular Systems, Inc. (1991) Summary page 1.
- K915723: .10' HI-Torque Floppy, Inter. & Stand. Guide Wire, Advanced Cardiovascular Systems, Inc. (1992) Summary page 1.
- K925381: Acs HI-Torque Balance (TM) Guide Wire, Advanced Cardiovascular Systems, Inc. (1993) Summary page 1.
- K934602: Acs.018 HI-Torque Floppy Guide Wire - Acs HI-Torque Floppy Extra Support Guide Wire, Advanced Cardiovascular Systems, Inc. (1993) Summary page 1.
- K942066: Acs HI-Torque Extra S'port Guide Wire, Advanced Cardiovascular Systems, Inc. (1994) Summary page 1.
- K950156: Acs HI-Torque Extra S'port (TM) Guide Wire, Advanced Cardiovascular Systems, Inc. (1995) Summary page 1.
- K884198: Target Therapeutics Seeker-16 Steerable Guidewire, Target Therapeutics (1988) Summary page 1.
- K922912: Seeker Lite - 10, Target Therapeutics (1992) Summary page 1.
- K914032: Nitinol Seeker (R) Guide Wires, Target Therapeutics (1992) Summary page 1.
- K924009: Intravascular Guide Wire and Extension Wire, Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard (1992) Summary page 1.
- K933466: Usci Mach 10 Guide Wire with Pro/Pel Coating, C.R. Bard, Inc. (1993) Summary page 1.

## Indications for use
The Braun Guidewire is intended to fit inside a catheter for the purpose of directing the catheter through a blood vessel. These catheters may be used for PTCA and PTA procedures. These guidewires are not intended for use for cerebral,reproductive,or nuerological procedures.

Source page: https://510kreport.com/device/K961107
Methodology: https://510kreport.com/methodology