MAJ · Catheter, Percutaneous, Intraspinal, Short Term
Anesthesiology · 21 CFR 868.5120 · Class 2
Overview
| Product Code | MAJ |
|---|---|
| Device Name | Catheter, Percutaneous, Intraspinal, Short Term |
| Regulation | 21 CFR 868.5120 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K965251 | MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM | Medtronic Vascular | Mar 18, 1997 | SESE |
| K945413 | MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT | Medtronic Vascular | May 24, 1995 | SESE |
| K934939 | TEMPORARY SCREENING LEAD/ CATHETER KIT | Medtronic Vascular | May 24, 1995 | SESE |
| K930218 | SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES | Concord/Portex | Jul 27, 1993 | SESE |
| K911382 | IPI ALGO-LINE CATHETER | Pudenz-Schulte Medical Research Corp. | Jul 18, 1991 | SESE |
| K893766 | LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE | Abbott Laboratories | Nov 1, 1989 | SESE |
Top Applicants
- Medtronic Vascular — 3 clearances
- Abbott Laboratories — 1 clearance
- Concord/Portex — 1 clearance
- Pudenz-Schulte Medical Research Corp. — 1 clearance
