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Percutaneous Catheters

by Micor, Inc. 2 variants

510(k) K861008

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK861008 Date29 Apr 1986ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Percutaneous Catheters are medical devices classified under the FDA Product Code DQY (Cardiovascular). These devices are designed for insertion into veins or arteries through the skin, typically using a dilator, sheath (introducer), or guide wire. They facilitate vascular access for diagnostic or therapeutic procedures, including fluid administration, pressure monitoring, or blood sampling. The catheters are intended for percutaneous (through-the-skin) application in cardiovascular interventions.

These catheters are supplied as single-use devices, as indicated by their regulatory submission. They are intended for use in clinical settings where sterile access to blood vessels is required, such as in cardiac catheterization labs or procedural suites. The FDA 510(k) clearance (K861008) confirms their substantial equivalence to a legally marketed predicate device, ensuring compliance with U.S. regulatory standards. No additional sterility or MRI safety information is provided in the available data.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are Micor Percutaneous Catheters used for?

    These catheters are designed for percutaneous insertion into veins or arteries to provide vascular access during diagnostic or therapeutic procedures. They enable fluid administration, pressure monitoring, or blood sampling in clinical settings like cardiac catheterization labs. The FDA 510(k) clearance (K861008) confirms their intended use aligns with established cardiovascular interventions.

  • Are Micor Percutaneous Catheters single-use or reusable?

    These catheters are explicitly supplied as single-use devices, as noted in their regulatory submission. This ensures sterility and safety for each procedure, reducing cross-contamination risks in clinical environments.

  • What types of procedures can these catheters support?

    The catheters facilitate vascular access for procedures requiring sterile entry into blood vessels, such as cardiac catheterization, fluid infusion, or blood pressure monitoring. Their design supports both diagnostic and therapeutic applications in cardiovascular interventions.

  • How are these catheters supplied for clinical use?

    They are packaged as single-use devices, ready for immediate sterile use in procedural settings. The packaging ensures no reuse, maintaining compliance with sterile technique requirements for vascular access.

  • What regulatory approval does Micor’s Percutaneous Catheters hold?

    The catheters hold FDA 510(k) clearance under reference number K861008, confirming substantial equivalence to a legally marketed predicate device. This clearance validates their compliance with U.S. regulatory standards for cardiovascular devices.