# K974241: Scimed Informer Pressure Wire System

- Pathway: 510(k) (Traditional)
- Applicant: Scimed Life Systems, Inc.
- Decided: Nov 12, 1998 after 365 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: 3 generations back to K941895 (1994). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943192: Scimed Choice (TM) Ptca Guide Wire, Scimed Life Systems, Inc. (1994) Summary page 3.
- K945129: Scimed Chioce Plus Ptca Guide Wire, Scimed Life Systems, Inc. (1995) Summary page 3.
- K950141: Scimed (R) Choice (TM) Ptca Guide Wire, Scimed Life Systems, Inc. (1995) Summary page 3.
- K950113: Scimed (R) Chice (TM) Exchange Ptca Guide Wire, Scimed Life Systems, Inc. (1995) Summary page 3.
- K961015: Scimed Choice/Ptca Guide Wire/Plus Ptca Guide Wire/Exchange Ptca Guide Wire, Scimed Life Systems, Inc. (1996) Summary page 3.
- K965023: Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide Wire, Scimed Life Systems, Inc. (1997). Our OCR of the scanned summary read K965063, FDA’s number for Audiotone (a-552) (Miracle-Ear, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CholCE Guide Wire”.
- K964551: Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice Exchange Super Support Ptca Guid, Scimed Life Systems, Inc. (1997) Summary page 3.
- K942333: Scimed EN Tre' Iii Ptca Guide Wire, Scimed Life Systems, Inc. (1994) Summary page 3.
- K946240: Scimed (R) Sceptor (TM) Ptca Guide Wire, Scimed Life Systems, Inc. (1995) Summary page 3.
- K950534: Scimed Sceptor Ptca Guide Wire, Scimed Life Systems, Inc. (1995) Summary page 3.
- K960563: Scimed Sceptor & Sceptor Exchange Ptca Guide Wires, Scimed Life Systems, Inc. (1996) Summary page 3.
- K910764: The Perceptor (TM) Stand Alone Transducer, North American Instrument Corp. (1991) Summary page 3.
- K942377: Transtar Pressure Transducer, Medex, Inc. (1994) Summary page 3.
- K925638: Phoenix Disposable Pressure Transducer #73-600, Baxter Healthcare Corp (1993) Summary page 3.
- K965140: Cardiometrics Wavewire/Wavemap Pressure System, Cardio Metrics, Inc. (1997) Summary page 3.

## Indications for use
The SCIMED Informer™ Pressure Wire System is intended to monitor the mean intravascular blood pressure and to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The phasic wave signal of the INFORMER Pressure Wire System is intended to facilitate placement of the wire. The INFORMER Pressure Wire is not intended for use in the cerebral vasculature. The SCIMED INFORMER Pressure Wire System is not intended to be used in combination with any H.F. surgical equipment. The SCIMED INFORMER Pressure Wire System is indicated for use with all physiological monitors that meet IEC 601-1, IEC 601-2-34 standards. These monitors are required to meet electrical isolation for Type CF applied parts.

Source page: https://510kreport.com/device/K974241
Methodology: https://510kreport.com/methodology