Mark II CO2 Flush Manometric Perfusion Pump & Mark II Manometric Perfusion Pump
510(k) K980946
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK980946 | Date8 Jun 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FFX
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1725
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Mark II CO₂ Flush Manometric Perfusion Pump and Mark II Manometric Perfusion Pump are classified as Systems, Gastrointestinal Motility (Electrical). These devices deliver constant gas pressure and constant flow perfusion, enabling multi-channel administration of perfusate while allowing connection to pressure transducers for monitoring intra-gastrointestinal pressures. The CO₂ flush variant incorporates carbon dioxide delivery for specific diagnostic procedures, such as esophageal or intestinal pressure studies. Both systems are designed to support functional assessments of gastrointestinal motility and pressure dynamics in clinical settings.
These devices are intended for use in controlled medical environments, such as gastroenterology and urology clinics or laboratories. Supplied as reusable medical equipment, they require proper cleaning, sterilization, and maintenance per manufacturer guidelines. The Mark II models adhere to IEC standards and have received FDA 510(k) clearance under the Traditional pathway, with the CO₂ flush variant classified under product code FFX. No specific MRI safety classification is noted, and storage conditions must align with the manufacturer’s instructions to preserve functionality and sterility.
Other devices from Dentsleeve Pty., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Mark II CO₂ Flush Manometric Perfusion Pump used for?
The Mark II CO₂ Flush Manometric Perfusion Pump is designed for controlled administration of perfusate during gastrointestinal motility studies. It delivers constant gas pressure and flow, enabling multi-channel perfusion while allowing connection to pressure transducers. The CO₂ flush variant is specifically intended for diagnostic procedures like esophageal or intestinal pressure assessments, helping clinicians evaluate gastrointestinal function in specialized environments such as gastroenterology or urology clinics.
How is the Mark II Perfusion Pump supplied and maintained?
The Mark II Perfusion Pump, including the CO₂ flush variant, is supplied as reusable medical equipment. Proper maintenance involves cleaning, sterilization, and adherence to manufacturer guidelines to ensure functionality and safety. Since it is reusable, it must be handled in accordance with clinical protocols to prevent cross-contamination and maintain performance standards.
Is the Mark II CO₂ Flush Perfusion Pump single-use or reusable?
The Mark II CO₂ Flush Perfusion Pump is designed as reusable equipment. Reusability requires strict adherence to cleaning, sterilization, and maintenance protocols to preserve its performance and ensure patient safety. The manufacturer provides specific instructions to support proper reuse in clinical settings.
What storage conditions are required for the Mark II Perfusion Pump?
The Mark II Perfusion Pump must be stored according to the manufacturer’s instructions to maintain functionality and sterility. Proper storage conditions help prevent damage, contamination, or degradation of components, ensuring the device remains operational for its intended clinical use in gastrointestinal motility assessments.
Does the Mark II Perfusion Pump have any specific regulatory approvals?
The Mark II CO₂ Flush Manometric Perfusion Pump and Mark II Manometric Perfusion Pump have received FDA 510(k) clearance under the Traditional pathway. The CO₂ flush variant is classified under product code FFX, indicating its regulatory classification for gastrointestinal motility systems. These approvals confirm compliance with U.S. safety and performance standards for medical devices.