THE AMPLATZ THROMBECTOMY DEVICE
Device Facts
| Record ID | K954205 |
|---|---|
| Device Name | THE AMPLATZ THROMBECTOMY DEVICE |
| Applicant | Microvena Corp. |
| Product Code | MCW · Cardiovascular |
| Decision Date | Aug 13, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4875 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Amplatz Thrombectomy Device is intended for mechanical dissolution of acute and subacute thrombus in dialysis fistulae. This device is not intended to be used for the removal of atheroma and is contraindicated in coronary, cerebral, and pulmonary vessels.
Device Story
Polyurethane catheter; distal rotor housing with recessed impeller attached to drive shaft; powered by disposable high-speed air-driven motor. Infusion line allows delivery of saline, contrast, or thrombolytic agents. Used by clinicians for mechanical thrombus dissolution in dialysis fistulae. Device functions by mechanical maceration of thrombus; output is cleared fistula. Benefits include minimally invasive alternative to surgical embolectomy.
Clinical Evidence
Clinical studies demonstrated device is as safe and effective as surgery for removal of acute and subacute thrombus in dialysis fistulae. Testing included design validation, animal studies, and clinical trials.
Technological Characteristics
Polyurethane catheter; distal rotor housing; recessed impeller; drive shaft; high-speed air-driven motor; infusion line with luer connector. Mechanical thrombus dissolution principle.
Indications for Use
Indicated for mechanical dissolution of acute and subacute thrombus in dialysis fistulae. Contraindicated for use in coronary, cerebral, and pulmonary vessels; not for removal of atheroma.
Regulatory Classification
Identification
An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)
Predicate Devices
- Fogarty Arterial Embolectomy Catheters (pre-amendment)
Related Devices
- K982657 — AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100 · Microvena Corp. · Nov 18, 1998
- K971984 — AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) · Microvena Corp. · Sep 19, 1997
- K091029 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) · Rex Medical · Feb 18, 2010
- K973669 — THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) · Micro Therapeutics, Inc. · Feb 6, 1998
- K031610 — REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM · Rex Medical · May 27, 2003
