7 mm Extended Length Endoscope
FDA 510(k) clearance K191930 · decided 2020-04-15
Clearance details
- K-number
- K191930
- Device name
- 7 mm Extended Length Endoscope
- Applicant
- Maquet Cardiovascular, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-07-19
- Decision date
- 2020-04-15
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Wayne, NJ, US
- Third-party review
- No
- Expedited review
- No
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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 |
|---|---|---|
| HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM (P840029/S007) | Maquet Cardiovascular, LLC | 1993-05-17 |
| HEMASHIELD ETS(TM) FLANGED GRAFT (P840029/S004) | Maquet Cardiovascular, LLC | 1993-05-17 |
| HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 12 X 6MM (P840029/S006) | Maquet Cardiovascular, LLC | 1993-05-17 |
| HEMASHIELD(R) MICROVEL (R) DOUBLE VELOUR GRAFT (P840029/S014) | Maquet Cardiovascular, LLC | 1993-05-17 |
| HEMASHIELD (R) MICROVEL (R) DOUBLE VELOUR (P840029/S011) | Maquet Cardiovascular, LLC | 1993-05-17 |
| HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS (P840029/S010) | Maquet Cardiovascular, LLC | 1993-05-11 |
| HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS (P840029/S009) | Maquet Cardiovascular, LLC | 1993-05-11 |
| HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS (P840029/S005) | Maquet Cardiovascular, LLC | 1993-05-11 |