Scimed Angiographic Kits

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K953265 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Triguide Guide Catheters

  Class II

  FDA 510(k) K953515 Active Cleared 19 Sep 1995

• Scimed Viper

  Class II

  FDA 510(k) K933183 Active Cleared 9 Sep 1993

• Scimed 7Fr and 8Fr Triguide Guiding Catheters

  Class II

  FDA 510(k) K914312 Active Cleared 22 Nov 1991

• Scimed Triguide Guide Catheter

  Class II

  FDA 510(k) K944537 Active Cleared 21 Oct 1994

• Scimed Pursuit Exchange Ptca Guide Wire

  Class II

  FDA 510(k) K945159 Active Cleared 30 Dec 1994

• Scimed(R) Controlwire(Tm) Guide Wire

  Class II

  FDA 510(k) K914194 Active Cleared 9 Jun 1992

See all devices from Scimed Life Systems, Inc. →

• What are Scimed Angiographic Kits used for?

  Scimed Angiographic Kits are designed for angiographic procedures to visualize blood vessels, particularly coronary arteries, using fluoroscopy or X-ray imaging. This aids in diagnosing and treating cardiovascular conditions by enabling clear visualization during catheterization, which is essential for interventions like angioplasty or stent placement.

• Are these kits supplied as a complete set or modular?

  The Scimed Angiographic Kits are supplied as either preassembled or modular sets, including angiographic catheters, guidewires, and associated accessories. This flexibility allows clinicians to choose the configuration that best fits their procedural needs while ensuring all necessary components are available for safe and effective use.

• Are these kits intended for single-use or reuse?

  While the provided data does not explicitly state sterility or reuse status, angiographic kits of this type are typically packaged in sterile conditions for single-use applications. Single-use ensures patient safety by eliminating cross-contamination risks and maintains device performance for one procedure.

• What regulatory pathway does this device follow?

  The Scimed Angiographic Kits follow the FDA 510(k) clearance pathway, specifically classified under product code DQY and reviewed by the Cardiovascular Advisory Committee. The clearance (K953265) was granted in 1996, confirming the device’s substantial equivalence to a predicate product for angiographic visualization in coronary procedures.

• How are these kits structured in terms of components?

  Each kit contains angiographic catheters, guidewires, and associated accessories tailored for coronary angiography. The modular or preassembled design ensures compatibility with fluoroscopy or X-ray imaging systems, providing clinicians with the tools needed to perform precise catheterization during interventional radiology or cardiology procedures.