SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES
FDA 510(k) clearance K930218 · decided 1993-07-27
Clearance details
- K-number
- K930218
- Device name
- SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES
- Applicant
- Concord/Portex
- Decision
- Substantially Equivalent
- Date received
- 1993-01-15
- Decision date
- 1993-07-27
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- MAJ
- Device class
- 2
- Regulation number
- 868.5120
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Keene, NH, 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.
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM (K965251) | Medtronic Vascular | 1997-03-18 |
| MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT (K945413) | Medtronic Vascular | 1995-05-24 |
| TEMPORARY SCREENING LEAD/ CATHETER KIT (K934939) | Medtronic Vascular | 1995-05-24 |
| IPI ALGO-LINE CATHETER (K911382) | Pudenz-Schulte Medical Research Corp. | 1991-07-18 |
| LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE (K893766) | Abbott Laboratories | 1989-11-01 |
Recalls involving this device
No recalls on record reference this clearance.