FDA product code MAJ: Catheter, Percutaneous, Intraspinal, Short Term
MAJ is the FDA product code for catheter, percutaneous, intraspinal, short term. It is a Class II device, regulated under 21 CFR 868.5120 and reviewed by the General Hospital panel. FDA has cleared 6 510(k) submissions under MAJ, from 4 different applicants. The average 510(k) review took 224 days (median 180).
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Percutaneous, Intraspinal, Short Term |
| Device class | Class II |
| Regulation | 21 CFR 868.5120 |
| Review panel | HO — General Hospital |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top MAJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Vascular | 3 | 1997-03-18 |
| Concord/Portex | 1 | 1993-07-27 |
| Pudenz-Schulte Medical Research Corp. | 1 | 1991-07-18 |
| Abbott Laboratories | 1 | 1989-11-01 |
Most recent MAJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K965251 | Medtronic Vascular | MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM | 1997-03-18 | 89 |
| K934939 | Medtronic Vascular | TEMPORARY SCREENING LEAD/ CATHETER KIT | 1995-05-24 | 583 |
| K945413 | Medtronic Vascular | MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT | 1995-05-24 | 202 |
| K930218 | Concord/Portex | SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES | 1993-07-27 | 193 |
| K911382 | Pudenz-Schulte Medical Research Corp. | IPI ALGO-LINE CATHETER | 1991-07-18 | 112 |
Recalls for MAJ devices
openFDA lists no recalls for product code MAJ.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)
Frequently asked questions
What is FDA product code MAJ?
MAJ is the FDA product code for catheter, percutaneous, intraspinal, short term. It is a Class II device, regulated under 21 CFR 868.5120 and reviewed by the General Hospital panel.
What device class is MAJ?
Class II, regulation 21 CFR 868.5120. Typical premarket route: 510(k).
How long does a 510(k) take for product code MAJ?
Across 6 cleared submissions the average was 224 days from receipt to decision (median 180).
Which companies have the most MAJ clearances?
Medtronic Vascular (3); Concord/Portex (1); Pudenz-Schulte Medical Research Corp. (1); Abbott Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MAJ
- Run a recall and safety report across every MAJ manufacturer
- Watch product code MAJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General Hospital product codes · FDA product code lookup