← Product Code [DXO](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO) · K141495
# TRUWAVE DISPOSABLE PRESSURE TRANSDUCER (K141495)
_Edwards Lifesciences, LLC · DXO · Sep 3, 2014 · Cardiovascular · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K141495
## Device Facts
- **Applicant:** Edwards Lifesciences, LLC
- **Product Code:** [DXO](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO.md)
- **Decision Date:** Sep 3, 2014
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2870
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
## Indications for Use
The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
## Device Story
The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is a sterile, single-use device designed for monitoring intravascular, intracranial, or intrauterine pressure. It features a straight, flow-through design where fluid passes across a pressure sensor. The kit includes a sterile cable (available in 30 cm or 120 cm lengths) that interfaces with an Edwards Lifesciences cable specifically wired for the patient monitor used to display pressure data. The device may include an integral flush device. It is intended for use in hospitals and clinical environments by healthcare professionals. The device provides real-time pressure data to the patient monitor, assisting clinicians in hemodynamic or pressure-related decision-making, thereby supporting patient management in critical care settings.
## Clinical Evidence
Bench testing only. No clinical data was required. The device underwent functional performance testing and biocompatibility testing in accordance with applicable consensus standards to demonstrate substantial equivalence.
## Technological Characteristics
Flow-through pressure transducer design; sterile, single-use; includes integral flush device option; cable lengths of 30 cm or 120 cm; biocompatible materials per ISO 10993; interfaces with patient monitors via proprietary cabling.
## Regulatory Identification
A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.
## Predicate Devices
- Phoenix Disposable Pressure Transducer #73-600 ([K925638](/device/K925638.md))
## Reference Devices
- VAMP ([K896819](/device/K896819.md))
## Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
September 3, 2014
Edwards Lifesciences, LLC. Mr. Andrew S. Mazurkiewicz, Jr., MBA/MKT Senior Associate, Regulatory Affairs Critical Care One Edwards Way, CA 92614
Re: K141495
> Trade/Device Names: Pressure Monitoring Kit with TruWave Disposable Pressure Transducers, with list of 577 models attached Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II (two) Product Code: DXO Dated: August 22, 2014 Received: August 25, 2014
Dear Mr. Mazurkiewicz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Page 2 – Mr. Andrew S. Mazurkiewicz, Jr.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# ATTACHMENT 1
## SUPPLEMENT TO TABLE 11-2: TRUWAVE MODELS
# (Total of 577 models)
{3}------------------------------------------------
| Supplement to Table 11-2: TruWave™ Models | | | | |
|-------------------------------------------|-------------------------------------|------------------------------------|-----------------------|---------------------------------------------------------|
| Model # | # of
Transducers
(P/N 500479) | Transducer
Flow Rate
(mL/hr) | Tubing Length
(cm) | Blood Sampling
Reservoir Size (cc)
VAMP (K896819) |
| PXMK2043 | 3 | 3 | 183 | N/A |
| PX284AN | 1 | 3 | 210 | N/A |
| PXMK1940 | 1 | 3 | 183 | N/A |
| PX2X2284C | 2 | 3 | 211 | N/A |
| PXMK2002 | 1 | 3 | 91 | N/A |
| PXMK478 | 1 | 3 | 150 | N/A |
| T494C00B | 2 | 3 | 180 | N/A |
| PXVMP260 | 1 | 3 | 150 | 5 |
| PXVP0861 | 2 | 3 | 170 | 12 |
| T001650A | 2 | 3 | 150 | N/A |
| VMP426PX | 1 | 3 | 66 | 3 |
| PXMK2041 | 1 | 3 | 183 | N/A |
| PXVP2284 | 1 | 3 | 210 | 12 |
| T001709A | 2 | 3 | 210 | N/A |
| T432105A | 1 | 30 | 130 | N/A |
| T322242B | 2 | 3 | 210 | N/A |
| T531401A | 2 | 3 | 0 | N/A |
| T434303A | 2 | 3 | 210 | 5 |
| T001759A | 2 | 3 | 171 | 12 |
| T001737A | 2 | 3 | 180 | 5 |
| PX12N | 1 | 30 | 30 | N/A |
| T001657A | 2 | 3 | 210 | N/A |
| T001775A | 1 | 3 | 195 | N/A |
| T433803A | 1 | 3 | 200 | N/A |
| PX200 | 1 | 3 | 0 | N/A |
| PX1X2 | 1 | 3 | 150 | N/A |
| PXVMP2X31 | 2 | 3 | 160 | 5 |
| PX6001 | 1 | 3 | 0 | N/A |
| PXMK1849 | 1 | 3 | 193 | N/A |
| T001633A | 1 | 3 | 150 | N/A |
| T001624A | 1 | 3 | 150 | N/A |
| T321571A | 2 | 3 | 165 | N/A |
| PXMK0666 | 2 | 3 | 208 | N/A |
| T001658A | 2 | 3 | 180 | N/A |
| PX2X2YB | 2 | 3 | 180 | N/A |
| T391T00A | 2 | 3 | 221 | 12 |
| T001712A | 2 | 3 | 195 | N/A |
| T441T01C | 1 | 3 | 225 | N/A |
| T491Y01B | 1 | 3 | 185 | N/A |
| T581203B | 1 | 3 | 210 | N/A |
| Supplement to Table 11-2: TruWave™ Models | | | | |
| Model # | # of
Transducers
(P/N 500479) | Transducer
Flow Rate
(mL/hr) | Tubing Length
(cm) | Blood Sampling
Reservoir Size (cc)
VAMP (K896819) |
| PXMK2043 | 3 | 3 | 183 | N/A |
| T530217B | 1 | 3 | 180 | N/A |
| VMP448PX | 1 | 3 | 122 | 3 |
| PXVP2284DZ | 1 | 3 | 210 | 12 |
| T001660A | 3 | 3 | 150 | N/A |
| T100202A | 1 | 3 | 105 | N/A |
| T001741A | 2 | 3 | 180 | 12 |
| PXVP0549 | 3 | 3 | 221 | 12 |
| PX3X3284C | 3 | 3 | 211 | N/A |
| PX2X3 | 2 | 3 | 150 | N/A |
| T005002A | 1 | 3 | 180 | N/A |
| T001745A | 1 | 3 | 180 | 12 |
| PX3X3 | 3 | 3 | 150 | N/A |
| PXVK0458 | 3 | 3 | 236 | 5 |
| PXVMP3X31 | 3 | 3 | 160 | 5 |
| PX600F | 1 | 3 | 0 | N/A |
| T005025A | 1 | 3 | 180 | N/A |
| PX4X4 | 4 | 3 | 211 | N/A |
| PX3X3AN | 3 | 3 | 211 | N/A |
| PXMK2011 | 1 | 3 | 196 | N/A |
| PXMK9146 | 2 | 3 | 178 | N/A |
| T001789B | 1 | 3 | 150 | N/A |
| T325202A | 1 | 3 | 150 | N/A |
| PX3X3272 | 3 | 3 | 178 | N/A |
| PXVMP172 | 1 | 3 | 180 | 5 |
| PX600F30 | 1 | 30 | 0 | N/A |
| PXMK053 | 1 | 3 | 210 | N/A |
| PXMK2008 | 1 | 3 | 180 | N/A |
| PXVP2284AT3 | 1 | 3 | 210 | 12 |
| PXVP23X3AT3 | 3 | 3 | 231 | 12 |
| PXVP2X2AT3 | 2 | 3 | 213 | 12 |
| PXVK0388 | 3 | 3 | 188 | N/A |
| PXCMK590 | 2 | 3 | 208 | N/A |
| PXVK0387 | 2 | 3 | 188 | N/A |
| PX266C | 1 | 3 | 168 | N/A |
| PXMK1479 | 1 | 3 | 148 | N/A |
| PXVP2272 | 1 | 3 | 180 | 12 |
| PX600 | 1 | 3 | 0 | N/A |
| PXMK0695 | 1 | 3 | 130 | N/A |
| PX284 | 1 | 3 | 210 | N/A |
{4}------------------------------------------------
{5}------------------------------------------------
| Supplement to Table 11-2: TruWave™ Models | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-------------------------------------------|-------------------------------------|------------------------------------|-----------------------|---------------------------------------------------------|----------|---|---|-----|-----|----------|---|---|-----|-----|----------|---|---|---|-----|----------|---|---|---|-----|----------|---|---|---|-----|----------|---|---|-----|-----|----------|---|---|-----|-----|----------|---|---|-----|-----|----------|---|---|-----|-----|----------|---|---|-----|-----|----------|---|---|-----|-----|----------|---|---|-----|-----|----------|---|---|---|-----|---------|---|---|----|-----|
| Model # | # of
Transducers
(P/N 500479) | Transducer
Flow Rate
(mL/hr) | Tubing Length
(cm) | Blood Sampling
Reservoir Size (cc)
VAMP (K896819) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXMK2043 | 3 | 3 | 183 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PX212 | 1 | 3 | 30 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXMK0976 | 2 | 3 | 147 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXVK0398 | 2 | 3 | 188 | 5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXVMP160 | 1 | 3 | 150 | 5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PX284R | 1 | 3 | 210 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXMK0688 | 1 | 30 | 119 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PX260
(Representative
Model) | 1 | 3 | 150 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PX272 | 1 | 3 | 180 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PX2X2 | 2 | 3 | 150 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXVMP120 | 1 | 3 | 50 | 5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXVP0897 | 3 | 3 | 193 | 12 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXVP23X3 | 3 | 3 | 170 | 12 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXVMP184 | 1 | 3 | 210 | 5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXVMP272 | 1 | 3 | 180 | 5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXVMP284 | 1 | 3 | 210 | 5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXVP2260 | 1 | 3 | 150 | 12 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| T001631A | 1 | 3 | 150 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| T001645A | 1 | 3 | 165 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| T001670A | 1 | 3 | 150 | 5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| T001671A | 1 | 3 | 180 | 5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| T001673A | 2 | 3 | 150 | 5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PX3X3MT | 3 | 3 | 211 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXMK1876 | 3 | 3 | 213 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXMK1805 | 3 | 3 | 211 | N/A | PXMK2012 | 4 | 3 | 196 | N/A | T100209A | 1 | 3 | 150 | N/A | PXAK1568 | 1 | 3 | 0 | N/A | PXAK2066 | 3 | 3 | 0 | N/A | PXAK2296 | 4 | 3 | 0 | N/A | PXMK0933 | 1 | 3 | 208 | N/A | PXMK1300 | 3 | 3 | 274 | N/A | PXMK1737 | 2 | 3 | 208 | N/A | PXMK1863 | 4 | 3 | 178 | N/A | PXMK2143 | 3 | 3 | 198 | N/A | PXMK2144 | 3 | 3 | 211 | N/A | PXMK2258 | 4 | 3 | 183 | N/A | PXMK2270 | 5 | 3 | 0 | N/A | PXMK560 | 2 | 3 | 30 | N/A |
| PXMK1805 | 3 | 3 | 211 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXMK2012 | 4 | 3 | 196 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| T100209A | 1 | 3 | 150 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXAK1568 | 1 | 3 | 0 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXAK2066 | 3 | 3 | 0 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXAK2296 | 4 | 3 | 0 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXMK0933 | 1 | 3 | 208 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXMK1300 | 3 | 3 | 274 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXMK1737 | 2 | 3 | 208 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXMK1863 | 4 | 3 | 178 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXMK2143 | 3 | 3 | 198 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXMK2144 | 3 | 3 | 211 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXMK2258 | 4 | 3 | 183 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXMK2270 | 5 | 3 | 0 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PXMK560 | 2 | 3 | 30 | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
{6}------------------------------------------------
| Supplement to Table 11-2: TruWave™ Models | | | | |
|--------------------------------------------|-------------------------------------|------------------------------------|-----------------------|---------------------------------------------------------|
| Model # | # of
Transducers
(P/N 500479) | Transducer
Flow Rate
(mL/hr) | Tubing Length
(cm) | Blood Sampling
Reservoir Size (cc)
VAMP (K896819) |
| PXMK2043 | 3 | 3 | 183 | N/A |
| PXVK0363 | 3 | 3 | 241 | 5 |
| PXVK0438 | 4 | 3 | 163 | 5 |
| PXVK0738 | 4 | 3 | 244 | 5 |
| PXVK0755 | 3 | 3 | 244 | 5 |
| PXVK0797 | 3 | 3 | 224 | 5 |
| PXVK0965 | 3 | 3 | 173 | 5 |
| PXVK1001 | 3 | 3 | 206 | 5 |
| PXVK1003 | 4 | 3 | 173 | 5 |
| PXVK1086 | 3 | 3 | 99 | 5 |
| PXVK268 | 3 | 3 | 203 | 5 |
| PXVP0686 | 2 | 3 | 220 | 12 |
| PXVP0812 | 3 | 3 | 155 | 12 |
| PXVP0880 | 3 | 3 | 231 | 12 |
| PXVP0902 | 3 | 3 | 206 | 12 |
| PXVP0966 | 3 | 3 | 231 | 12 |
| PXVP1066 | 3 | 3 | 177 | 12 |
| PXVP1087 | 4 | 3 | 199 | 12 |
| T493Y02B | 3 | 3 | 195 | N/A |
| T001619A | 1 | 3 | 30 | N/A |
| T310195A | 1 | 30 | 150 | N/A |
| T001691A | 1 | 3 | 171 | 12 |
| T100214A | 1 | 3 | 180 | N/A |
| T100215A | 1 | 3 | 210 | N/A |
| T430023B | 2 | 3 | 215 | 12 |
| T001702A | 2 | 3 | 135 | N/A |
| T001724A | 1 | 3 | 210 | N/A |
| T001758A | 1 | 3 | 0 | N/A |
| T001760A | 2 | 3 | 171 | 12 |
| T001786A | 2 | 3 | 195 | N/A |
| T005004A | 1 | 3 | 150 | N/A |
| T005052A | 1 | 3 | 210 | N/A |
| T005074A | 2 | 3 | 175 | 12 |
| T005080A | 1 | 3 | 180 | N/A |
| T100212A | 1 | 3 | 150 | N/A |
| T100500A | 1 | 3 | 60 | 5 |
| T100504A | 1 | 3 | 190 | 5 |
| T100671B | 3 | 3 | 171 | 12 |
| T330639B | 2 | 3 | 150 | N/A |
| T330831A | 1 | 3 | 210 | N/A |
| Supplement to Table 11-2: TruWaveTM Models | | | | |
| Model # | # of
Transducers
(P/N 500479) | Transducer
Flow Rate
(mL/hr) | Tubing Length
(cm) | Blood Sampling
Reservoir Size (cc)
VAMP (K896819) |
| PXMK2043 | 3 | 3 | 183 | N/A |
| T330918A | 2 | 3 | 200 | N/A |
| T330919A | 1 | 3 | 200 | N/A |
| T330V11A | 3 | 3 | 200 | N/A |
| T331E02A | 1 | 3 | 0 | N/A |
| T331F06B | 1 | 3 | 90 | N/A |
| T331S05B | 2 | 3 | 200 | N/A |
| T332J01A | 1 | 3 | 150 | N/A |
| T333529A | 2 | 3 | 150 | N/A |
| T333709B | 2 | 3 | 0 | N/A |
| T333710C | 2 | 3 | 0 | N/A |
| T333918A | 2 | 3 | 210 | N/A |
| T333919A | 1 | 3 | 150 | N/A |
| T333C00A | 1 | 3 | 180 | N/A |
| T333D00A | 1 | 3 | 150 | N/A |
| T333F00A | 1 | 3 | 210 | N/A |
| T334041A | 2 | 3 | 180 | N/A |
| T334402A | 2 | 3 | 180 | N/A |
| T334708C | 1 | 3 | 0 | N/A |
| T336546B | 2 | 3 | 197 | 12 |
| T336547B | 3 | 3 | 197 | 12 |
| T336548B | 1 | 3 | 197 | 12 |
| T337003A | 1 | 3 | 150 | N/A |
| T337119B | 2 | 3 | 200 | N/A |
| T337305B | 3 | 3 | 240 | N/A |
| T391T01A | 3 | 3 | 221 | 12 |
| T441809C | 2 | 3 | 150 | N/A |
| T450552C | 1 | 30 | 156 | 3 |
| T491U01B | 1 | 3 | 180 | N/A |
| T492011A | 3 | 3 | 135 | N/A |
| T493Y03B | 1 | 30 | 156 | N/A |
| T495009A | 3 | 3 | 175 | N/A |
| T321570A | 1 | 3 | 120 | N/A |
| T321572A | 3 | 3 | 150 | N/A |
| T321573A | 1 | 3 | 165 | N/A |
| T321575A | 1 | 3 | 105 | N/A |
| T449103B | 2 | 3 | 160 | 5 |
| T100209A | 1 | 3 | 150 | N/A |
| T391314A | 3 | 3 | 210 | N/A |
| T770000A | 1 | 3 | 210 | 5 |
| Supplement to Table 11-2: TruWave™ Models | | | | |
| Model # | # of
Transducers
(P/N 500479) | Transducer
Flow Rate
(mL/hr) | Tubing Length
(cm) | Blood Sampling
Reservoir Size (cc)
VAMP (K896819) |
| PXMK2043 | 3 | 3 | 183 | N/A |
| T005086A | 1 | 3 | 210 | N/A |
| T440B26B | 2 | 3 | 200 | 5 |
| T321811A | 1 | 3 | 162 | 5 |
| T321811Z | 1 | 3 | 162 | 5 |
| T443422A | 2 | 3 | 210 | N/A |
| T391312A | 1 | 3 | 210 | N/A |
| T320161B | 1 | 3 | 150 | N/A |
| T460061A | 1 | 3 | 195 | N/A |
| T341211A | 1 | 3 | 0 | N/A |
| T433202B | 1 | 3 | 210 | N/A |
| T460225D | 3 | 3 | 205 | N/A |
| T395705A | 1 | 3 | 180 | N/A |
| T322241A | 1 | 3 | 150 | N/A |
| T325615A | 1 | 3 | 195 | N/A |
| T398807D | 1 | 3 | 58 | 12 |
| T531900A | 1 | 3 | 55 | N/A |
| T341210A | 1 | 3 | 150 | N/A |
| T397705B | 2 | 3 | 180 | N/A |
| T433802A | 1 | 3 | 220 | 5 |
| T320943A | 2 | 3 | 120 | N/A |
| T320940B | 3 | 3 | 120 | N/A |
| PXVJ0441 | 1 | 30 | 168 | 3 |
| T005094A | 1 | 3 | 150 | N/A |
| T430181A | 1 | 3 | 221 | 5 |
| PX601 | 1 | 3 | 0 | N/A |
| T395606B | 3 | 3 | 180 | N/A |
| T451703A | 3 | 3 | 215 | 12 |
| T451703A | 3 | 3 | 215 | 12 |
| T433806A | 2 | 3 | 220 | 5 |
| T310682A | 3 | 3 | 150 | N/A |
| T432703A | 2 | 3 | 220 | 5 |
| T349302A | 1 | 30 | 150 | N/A |
| T530317A | 1 | 3 | 30 | N/A |
| T413405A | 1 | 3 | 150 | N/A |
| T431305A | 3 | 3 | 190 | 5 |
| T320162C | 2 | 3 | 60 | N/A |
| T349301B | 1 | 3 | 180 | N/A |
| T328500A | 1 | 3 | 180 | N/A |
| PXMK0010 | 1 | 3 | 230 | N/A |
| Supplement to Table 11-2: TruWave™ Models | | | | |
| Model # | # of
Transducers
(P/N 500479) | Transducer
Flow Rate
(mL/hr) | Tubing Length
(cm) | Blood Sampling
Reservoir Size (cc)
VAMP (K896819) |
| PXMK2043 | 3 | 3 | 183 | N/A |
| PXMK0011 | 2 | 3 | 230 | N/A |
| PXMK0012 | 3 | 3 | 230 | N/A |
| PXMK0013 | 1 | 3 | 0 | N/A |
| PXMK0014 | 1 | 3 | 150 | N/A |
| T610002A | 1 | 3 | 30 | N/A |
| PXMK2329 | 2 | 3 | 89 | N/A |
| PXMK2330 | 3 | 3 | 119 | N/A |
| T413675A | 2 | 3 | 225 | N/A |
| T397704A | 1 | 3 | 180 | N/A |
| T001725A | 1 | 3 | 150 | N/A |
| T322238A | 1 | 3 | 190 | N/A |
| T322515A | చి | చి | 180 | N/A |
| T398603A | 2 | 3 | 220 | 5 |
| T001744A | 1 | 3 | 220 | 5 |
| T323922D | 2 | 3 | 180 | N/A |
| T434304A | 1 | 3 | 190 | 5 |
| T433204B | 1 | 3 | 210 | N/A |
| PX24N | 1 | 30 | 60 | N/A |
| T323923A | 1 | 3 | 30 | N/A |
| T433801A | 1 | 3 | 200 | N/A |
| T430142A | 4 | 3 | 150 | N/A |
| T312306A | 1 | 3 | 15 | N/A…
---
**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K141495](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K141495)
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