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Reavillmed Pressure Monitoring System and PICC

by Reavillmed

510(k) K101189

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 NumberK101189 Date22 Dec 2010ClearedStatusActive

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  • Withdrawn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
DRS
Device Class
Class II
Regulation
21 CFR Part 870.2850
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The Reavillmed Pressure Monitoring System and PICC is a combination device comprising a blood pressure monitoring line, disposable pressure transducer, and single-lumen polyurethane reverse taper PICC. It is intended for short term peripheral access to the central venous system.

The device is supplied as a combination system with a blood pressure monitoring line, disposable pressure transducer, and single-lumen polyurethane reverse taper PICC. It is regulated under FDA 510(k) with product code DRS and regulation number 870.2850, classified as a Transducer, Blood-pressure, Extravascular in the Cardiovascular medical specialty.

Questions

AI-generated answers, 23 Sep 2026

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

  • What is the Reavillmed Pressure Monitoring System and PICC used for?

    The Reavillmed Pressure Monitoring System and PICC is a combination device designed for short term peripheral access to the central venous system. It includes a blood pressure monitoring line, disposable pressure transducer, and single-lumen polyurethane reverse taper PICC.

  • How is the Reavillmed Pressure Monitoring System and PICC supplied?

    The device is supplied as a complete combination system that includes a blood pressure monitoring line, a disposable pressure transducer, and a single-lumen polyurethane reverse taper PICC, all packaged together for clinical use.

  • What is the regulatory classification of the Reavillmed Pressure Monitoring System and PICC?

    The device is regulated under FDA 510(k) with product code DRS and regulation number 870.2850, classified as a Transducer, Blood-pressure, Extravascular in the Cardiovascular medical specialty. It received FDA clearance in 2010.

  • Is the Reavillmed Pressure Monitoring System and PICC designed for single-use or reuse?

    The device includes a disposable pressure transducer, which is designed for single-use to maintain sterility and prevent cross-contamination. The PICC component is also intended for single-use in clinical settings.