IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY
FDA 510(k) clearance K854997 · decided 1986-02-12
Clearance details
- K-number
- K854997
- Device name
- IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY
- Applicant
- Telectronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-12-12
- Decision date
- 1986-02-12
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- DTD
- Device class
- 2
- Regulation number
- 870.3620
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Suffield, CT, 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 |
|---|---|---|
| TELECTRONICS PASAR MODEL 4171 PG (P850027/S006) | Telectronics, Inc. | 1990-05-09 |
| TELECTRONICS PASAR MODEL 4171 PG (P850027/S003) | Telectronics, Inc. | 1990-03-22 |
| TELECTRONICS PASAR MODEL 4171 PG (P850027/S005) | Telectronics, Inc. | 1990-02-02 |
| TELECTRONICS PASAR MODEL 4171 PG (P850027/S002) | Telectronics, Inc. | 1989-04-18 |
| TELECTRONICS PASAR MODEL 4171 PG (P850027/S001) | Telectronics, Inc. | 1987-03-27 |
| TELECTRONICS PASAR MODEL 4171 PG (P850027) | Telectronics, Inc. | 1986-09-30 |