MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX
FDA 510(k) clearance K101784 · decided 2010-11-26
Clearance details
- K-number
- K101784
- Device name
- MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX
- Applicant
- Great Batch Medical
- Decision
- Substantially Equivalent
- Date received
- 2010-06-25
- Decision date
- 2010-11-26
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, recall (Z-0611-2013) | Greatbatch Medical | 2012-12-22 |
| Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, recall (Z-0132-2013) | Greatbatch Medical | 2012-10-24 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Myopore® Sutureless Myocardial Pacing Lead (P130012/S016) | Great Batch Medical | 2024-04-19 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S015) | Great Batch Medical | 2023-12-13 |
| Myopore® Sutureless Myocardial Pacing Lead (P130012/S014) | Great Batch Medical | 2023-07-07 |
| Myopore® Sutureless Myocardial Pacing Lead (P130012/S013) | Great Batch Medical | 2023-02-07 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S010) | Great Batch Medical | 2022-12-12 |
| Myopore® Sutureless Myocardial Pacing Lead (P130012/S009) | Great Batch Medical | 2022-10-05 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S007) | Great Batch Medical | 2019-07-15 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S008) | Great Batch Medical | 2019-07-03 |