MODIFICATION TO ACS CORONARY GUIDING
FDA 510(k) clearance K841992 · decided 1984-06-11
Clearance details
- K-number
- K841992
- Device name
- MODIFICATION TO ACS CORONARY GUIDING
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-04-25
- Decision date
- 1984-06-11
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- DAO
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 (K040431) | Roche Diagnostics Corp. | 2004-03-10 |
| SPIFE URINE IFE (K982639) | Helena Laboratories | 1998-11-04 |
| BOEHRINGER MANNHEIM IGM ASSAY (K955908) | Boehringer Mannheim Corp. | 1996-02-09 |
| SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M (K850586) | Applications Lab | 1985-03-14 |
| IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM (K812487) | Dako Corp. | 1981-09-23 |
| GEMENI IGM ASSAY (K800450) | Electro-Nucleonics Laboratories, Inc. | 1980-04-24 |
| ANTISERUM TO HUMAN IGM (K790705) | Kent Laboratories, Inc. | 1979-04-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CORONARY DILATATION CATHETERS (P810046/S240) | Advanced Cardiovascular Systems, Inc. | 2010-10-15 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S237) | Advanced Cardiovascular Systems, Inc. | 2010-06-01 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S238) | Advanced Cardiovascular Systems, Inc. | 2010-05-13 |
| SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETERS VOYAGER/VOYAGER NC (P810046/S236) | Advanced Cardiovascular Systems, Inc. | 2010-04-23 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S234) | Advanced Cardiovascular Systems, Inc. | 2010-03-26 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S232) | Advanced Cardiovascular Systems, Inc. | 2010-02-04 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S230) | Advanced Cardiovascular Systems, Inc. | 2009-07-15 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S231) | Advanced Cardiovascular Systems, Inc. | 2009-05-26 |