Percutaneous Angiographic Needles

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K845037 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Foam Nose

  Class I

  FDA 510(k) K840399 Active Cleared 16 Mar 1984

• Isotonic Diluent

  Class I

  FDA 510(k) K781008 Active Cleared 28 Jun 1978

• Hi-Lo Temp Thermocouple to Thermister Adaptor

  Class II

  FDA 510(k) K844201 Active Cleared 4 Mar 1985

• Glucose Reagent (O-Toluidine)

  Class II

  FDA 510(k) K771314 Active Cleared 3 Aug 1977

• Ria Quant C-Peptide Kit

  Class I

  FDA 510(k) K812689 Active Cleared 6 Oct 1981

• Hi-Lo Temp(R) Model 8700 Patient Temp Monitor

  Class II

  FDA 510(k) K874568 Active Cleared 6 Jan 1988

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• What are percutaneous angiographic needles used for?

  Percutaneous angiographic needles are used to gain vascular access during angiographic procedures by facilitating the introduction of catheters or other instruments into blood vessels percutaneously.

• Are these needles sterile or non-sterile when supplied?

  These percutaneous angiographic needles are supplied as non-sterile devices, meaning they must be sterilized by the user before clinical use in accordance with institutional protocols.

• Can these needles be reused after use?

  Yes, these needles are designed as reusable devices, intended for multiple uses after proper cleaning, disinfection, and sterilization between procedures in clinical settings.

• What regulatory pathway was used for clearance of this device?

  The percutaneous angiographic needles were cleared via the FDA 510(k) pathway under submission K845037, receiving a traditional clearance on June 21, 1985, based on substantial equivalence to a predicate device.