(196 days)
The Micro Therapeutics, Inc. Occlusion Balloon Catheter is designed for use in blood vessels where temporary occlusion is desired. The MTI Occlusion Balloon Catheter offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow.
The Equinox™ Occlusion Balloon Catheter is a single lumen balloon catheter with a maximum outer diameter of 2.8F tapering to 2.2F at the distal tip. The distal end of the catheter has a non-detachable low inflation pressure compliant balloon. The catheter is designed to track over the MTI SilverSpeed™ 0.010" guidewire, and requires insertion of the guidewire to occlude the catheter shaft lumen to allow inflation of the balloon. Two platinum markers provide angiographic visualization of the balloon length and facilitate intravascular placement of the balloon prior to inflation. The catheter shaft is hydrophilically coated to assist catheter advancement within the vasculature. The Equinox catheter is supplied sterile for single use as a system which includes the required SilverSpeed .010" Guidewire and a rotating hemostatic valve.
The Equinox™ Occlusion Balloon Catheter (K990487) did not present specific acceptance criteria in the provided 510(k) summary. Instead, it relied on demonstrating conformance to established international standards for medical devices and establishing substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Conformance to ISO 10993-1 | Test results confirmed biocompatibility of the Equinox catheter when tested as an external communicating, blood contact, short duration ( |
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).