(27 days)
The Equalizer Balloon is indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.
The Equalizer Balloon Catheter is designed for temporary occlusion of vessels up to 40mm in diameter. To allow for large inflation diameters, the balloons are mounted on a non-tapered catheter shaft. All Equalizer Balloon Catheters have two lumens that are marked. The tubing, marked BALLOON, is the balloon inflation lumen. The tubing marked DISTAL is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. The lumen can also be used for infusion of contrast medium. The Equalizer Balloon Catheter is constructed of a soft compliant latex balloon mounted on the tip of a multi-lumen nylon catheter shaft. Radiopaque markers are placed adjacent to the balloon segment of the catheter to provide visual reference points for balloon positioning within the vessel. Catheter shafts are radiopaque, maximizing fluoroscopic visibility.
The provided document is a 510(k) premarket notification for a medical device (Equalizer Occlusion Balloon Catheter). It does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices, discussing:
- General Provisions: Trade Name, Classification Name, Predicate Devices, Classification, Performance Standards (not established by FDA), Intended Use and Device Description.
- Biocompatibility: Stating no new materials were introduced and predicate devices were tested.
- Summary of Substantial Equivalence: Concluding that the device is substantially equivalent based on gathered data without raising new safety or efficacy issues.
- FDA Correspondence: Confirming substantial equivalence.
- Indications for Use: Listing the medical applications for the device.
There is no data, study design, acceptance criteria, or performance metrics described in this document that would allow for the completion of the requested table and information about a clinical or performance study. This type of regulatory submission typically relies on substantial equivalence to existing devices rather than new performance studies with specific acceptance criteria.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).