510(k) K965251
- Device
- Medtronic Algoline Intraspinal Catheter System
- Applicant
- MEDTRONIC VASCULAR
- 510(k) number
- K965251
- Product code
- MAJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-03-18
- Date received
- 1996-12-19
- Regulation
- 868.5120
- Classification name
- Catheter, Percutaneous, Intraspinal, Short Term
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PATRICK L JOHNSON
- Address
- 800 53rd Ave., NE P.O. Box 1250 Minneapolis MN US 55440 55440
FDA Registration Numbers#
- 9681477
- 9612501
- 3018094310
- 3015531529
- 3017636737
- 2011171
Source Documents#
Other 510(k) Records For Product Code MAJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K934939 | TEMPORARY SCREENING LEAD/ CATHETER KIT | Medtronic Vascular | 1995-05-24 |
| K945413 | MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT | Medtronic Vascular | 1995-05-24 |
| K930218 | SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES | Concord/Portex | 1993-07-27 |
| K911382 | IPI ALGO-LINE CATHETER | Pudenz-Schulte Medical Research Corp. | 1991-07-18 |
| K893766 | LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE | Abbott Laboratories | 1989-11-01 |