FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX
FDA 510(k) clearance K001367 · decided 2000-05-31
Clearance details
- K-number
- K001367
- Device name
- FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX
- Applicant
- St. Jude Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-05-01
- Decision date
- 2000-05-31
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch St. Jude Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S094) | St. Jude Medical, Inc. | 2016-02-12 |
| SENSOLOG / DIALOG/ REGENCY FAMILY OF PACEMAKERS (P880006/S093) | St. Jude Medical, Inc. | 2015-08-27 |
| SESOLOG / DIALOG / REGENCY FAMILY OF PACEMAKERS (P880006/S092) | St. Jude Medical, Inc. | 2015-02-25 |
| SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S089) | St. Jude Medical, Inc. | 2014-09-12 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S088) | St. Jude Medical, Inc. | 2014-05-29 |
| SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S081) | St. Jude Medical, Inc. | 2014-04-10 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S085) | St. Jude Medical, Inc. | 2014-03-20 |
| SENSOLOG/DIALOG/ REGENCY FAMILY OF PACEMAKERS (P880006/S087) | St. Jude Medical, Inc. | 2014-02-26 |