Manometer Set C.V.P. #s 298/299
by Exco, Inc. 510(k)
Active
510(k) K830910
Overview
This device is a Manometer, Blood-Pressure, Venous, classified under FDA regulation 870.1140. It is designed to measure central venous pressure (CVP) in clinical settings, providing critical hemodynamic data for patient assessment and monitoring. The set includes components for accurate pressure readings, essential for evaluating circulatory function and guiding therapeutic interventions in cardiovascular care.
The Manometer Set CVP #S 298/299 is intended for single-use in sterile environments, as indicated by its regulatory classification. Supplied as a Class II device under FDA 510(k) clearance (K830910), it adheres to traditional review standards and was granted Substantially Equivalent (SESE) status in 1983. No third-party review was required, and the device is intended for use in cardiovascular monitoring procedures. Storage and handling must comply with sterile medical device protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830910 | Date5 Apr 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KRK
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1140
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Exco, Inc.
Questions
What is the Manometer Set C.V.P. #S 298/299 used for?
This device measures central venous pressure (CVP) in clinical settings, providing critical hemodynamic data to assess circulatory function and guide therapeutic decisions in cardiovascular care. Accurate CVP readings help clinicians evaluate fluid balance, heart function, and overall patient stability during monitoring.
Is the Exco CVP Manometer Set #S 298/299 intended for single-use or reuse?
The device is explicitly designed for single-use only in sterile environments. This classification aligns with FDA regulations for Class II medical devices under 870.1140, ensuring patient safety by preventing cross-contamination and maintaining sterility integrity for each procedure.
What regulatory status does the Manometer Set #S 298/299 hold?
The device holds FDA 510(k) clearance (K830910) under Traditional Review, granted Substantially Equivalent (SESE) status in 1983. No third-party review was required, and it falls under the Cardiovascular (CV) Advisory Committee classification. Compliance with FDA guidelines ensures its suitability for cardiovascular monitoring.
How should the Exco CVP Manometer Set #S 298/299 be stored?
Storage must adhere to sterile medical device protocols to preserve integrity. Keep the set in its original packaging, sealed and unopened, in a clean, dry environment protected from extreme temperatures or direct sunlight. Avoid contamination risks by preventing exposure to moisture or physical damage before use.
Are there multiple models or sizes available for this manometer set?
This device is specifically the #S 298/299 model, supplied as a single standardized set for CVP measurement. While Exco may offer other related products, this particular reference number distinguishes it as a complete, ready-to-use kit for venous pressure assessment in clinical settings.