IMPLANT AID SPLICING CRIMP & SLEEVE
FDA 510(k) clearance K813518 · decided 1982-01-12
Clearance details
- K-number
- K813518
- Device name
- IMPLANT AID SPLICING CRIMP & SLEEVE
- Applicant
- Intermedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-16
- Decision date
- 1982-01-12
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- KFJ
- Device class
- 3
- Regulation number
- 870.3710
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Intermedics
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.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UNIVERSAL TERMINAL CAP, 3.2MM (K913919) | Telectronics Pacing Systems, Inc. | 1991-12-31 |
| MEDTRONIC MODEL 5867-1A (K852236) | Medtronic Vascular | 1985-07-11 |
Recalls involving this device
No recalls on record reference this clearance.