IMPLANTABLE VENTRICULAR-INHIBITED CARDI
FDA 510(k) clearance K802175 · decided 1981-02-05
Clearance details
- K-number
- K802175
- Device name
- IMPLANTABLE VENTRICULAR-INHIBITED CARDI
- Applicant
- Telectronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-09-09
- Decision date
- 1981-02-05
- Days to decision
- 149 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Telectronics
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.
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 |