NEW LEAD INTRODUCER KITS, VARIOUS MODELS
FDA 510(k) clearance K926340 · decided 1993-05-27
Clearance details
- K-number
- K926340
- Device name
- NEW LEAD INTRODUCER KITS, VARIOUS MODELS
- Applicant
- Telectronics Pacing Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-12-17
- Decision date
- 1993-05-27
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Washington, DC, 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 |
|---|---|---|
| GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB. (P940024) | Telectronics Pacing Systems, Inc. | 1997-07-03 |
| GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S032) | Telectronics Pacing Systems, Inc. | 1990-05-09 |
| SEQUICOR SERIES PULSE GEN. MODELS 233F,233G,& 240G (P820014/S044) | Telectronics Pacing Systems, Inc. | 1990-05-09 |
| GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S030) | Telectronics Pacing Systems, Inc. | 1990-03-22 |
| CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S042) | Telectronics Pacing Systems, Inc. | 1990-03-22 |
| GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S031) | Telectronics Pacing Systems, Inc. | 1990-02-02 |
| CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S043) | Telectronics Pacing Systems, Inc. | 1990-02-02 |
| CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S041) | Telectronics Pacing Systems, Inc. | 1989-04-18 |