Micrus Endovascular Corporation
Sunnyvale, CA, US
Micrus Endovascular Corporation appears in FDA device records in Sunnyvale, CA. FDA records list 23 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Micrus Endovascular Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131recall
510(k) clearance history
FDA records hold 23 510(k) clearances for Micrus Endovascular Corporation between 2005 and 2011. The busiest year on record is 2007, with 6. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 4 |
| 2007 | 6 |
| 2008 | 5 |
| 2009 | 5 |
| 2010 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K103780 | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO | MJN | Substantially Equivalent | |
| K102818 | MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE | DQX | Substantially Equivalent | |
| K092702 | MICRUS MICROCATHETER, MODEL COURIER 270 | DQO | Substantially Equivalent | |
| K091504 | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00 | MJN | Substantially Equivalent | |
| K083922 | MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 | DQO | Substantially Equivalent | |
| K090274 | MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE | DQX | Substantially Equivalent | |
| K083646 | MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL | HCG | Substantially Equivalent | |
| K082739 | MICRUS MICROCOIL DELIVERY SYSTEM | HCG | Substantially Equivalent | |
| K080861 | MICRUS ASCENT OCCLUSION BALLOON CATHETER | MJN | Substantially Equivalent | |
| K080379 | MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT | HCG | Substantially Equivalent | |
| K080437 | MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF | HCG | Substantially Equivalent | |
| K073442 | MICRUS MICROCOIL SYSTEMS | HCG | Substantially Equivalent | |
| K072526 | MICRUS COURIER ENZO MICROCATHETER 0.0190 | DQO | Substantially Equivalent | |
| K072173 | MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC | HCG | Substantially Equivalent | |
| K071246 | MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR | HCG | Substantially Equivalent | |
| K070456 | MICRUS COURIER ENZO MICROCATHETER 0.017 | DQO | Substantially Equivalent | |
| K070707 | MICRUS MICROCOIL SYSTEM | HCG | Substantially Equivalent | |
| K063653 | MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC | HCG | Substantially Equivalent | |
| K062036 | MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4 | HCG | Substantially Equivalent | |
| K061963 | MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00 | DQO | Substantially Equivalent | |
| K060116 | MICRUS COURIER MICROCATHETERS | DQO | Substantially Equivalent | |
| K053265 | MICRUS GUIDE WIRE, WATUSI 0.014 | DQX | Substantially Equivalent | |
| K053160 | MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE | HCG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0845-2011 | Micrus Endovascular Microcoil Delivery System; The Micrus Microcoil Delivery System consists of three components, a Microcoil System, a Connecting Cable, and a Detachment Control Box (DCB). Each component is sold separately. Catalog Numbers: PC4180933, SSR181128, CPL100252, PC4181647, SSR181640, CPL100404, DFS100254, SSR181230, CPL100406, DFS100410, DPL100206, SRC141230, CRC140304, DFS100716, CRC140406, CPL100203, DFS100204, DPL100408, SSR100253, PC4181240, DPL100202, CDF100408, PC4181137, CSP100500, CDF100154, PC4180830, CSP100350, DFS100152, SRC140408, PC4181034, CPL100206, CDF100152, SRC141025, SRC140225, CPL100304, CRC141025, CPL 100254, PC4181447, DPL100252, DFS100154, SRC140303, DFS100720, DPL 100204, PC4181343, CSP180500, DFS1 0031 0, DPL100306, DPL100256, CPL100306, CDF100304, CDF100203, CDF100410, PC4100412, DPL 100254, DPL 100053, PC41 00626, CDF100208, CRC140306, PC4100517, DFS100203, CSP181400, CPL 100152, DFS100210, CDF100720, CPL100204, CSP180200, DFS100204, CDF100510, DFS101025, DFS100408, PC41 00730, SSR181740, CRC140615, CPL100256, CDF100206, DFS100308, CPL100151, CSP100200, CDF100616, CRC140711, SSR181334, CDF100310, SRC140445, DFS100252, CPL100408, CDF100306, DFS100250, DPL 100152, DPL 100201, CDF100258, SRC140306, CDF100156, DPL 100153, DPL100304, SRC140922, SSR100825, DFS100206, DPL 100203, PC4181550, DFS100616, CSP180900, PC4181950, DFS100406, SRC140717, PC4181750, DFS100925, CSP100400, PC4181846, SRC140711, CPL100153, PC4182050, DFS100306, SRC140406, CSP100900, SRC140615, CDF100308, CSP100300, DFS1 0051 0, CDF100406, CDF1 0021 0, DFS100156, CDF100515, DPL100151, CDF100925, SSR181028, CDF101025, SSR181540, CPL 100201, SSR180825, CPL 100202; Manufactured and distributed by Micrus Endovascular Corporation, San Jose, CA | The firm has received reports of difficulty connecting to the detachment control cable. Loss of the electrical connection will result in failure to detach the coil for deployment inside an aneurysm. | Terminated | ||
| Z-1542-06 | Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST 140205-00; Distributed by Micrus Endovascular Corporation. San Jose, CA | During use, the introducer may cause the guide wire''s coating to strip off and may result in loose material which could break free and enter the blood stream. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain