Catheter, Percutaneous, Intraspinal, Short Term
The short-term percutaneous intraspinal catheter is an anesthesiology device inserted through the skin into the spinal canal to deliver anesthetic or analgesic agents for pain management. It is classified as FDA Class II under 21 CFR 868.5120, requiring 510(k) premarket clearance, and is eligible for third-party review as indicated by its third-party flag. The product code is MAJ and it is reviewed under the Hematology/Oncology panel despite its Anesthesiology specialty designation. Full GMP compliance is required and the device is not implanted long-term.
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Basic Information
- Product Code
- MAJ
- Device Class
- FDA class 2
- Regulation Number
- 868.5120
- Medical Specialty
- Anesthesiology
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K965251 | MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM | Mar 18, 1997 | Substantially Equivalent | Medtronic Vascular |
| K945413 | MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT | May 24, 1995 | Substantially Equivalent | Medtronic Vascular |
| K934939 | TEMPORARY SCREENING LEAD/ CATHETER KIT | May 24, 1995 | Substantially Equivalent | Medtronic Vascular |
| K930218 | SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES | Jul 27, 1993 | Substantially Equivalent | Concord/Portex |
| K911382 | IPI ALGO-LINE CATHETER | Jul 18, 1991 | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. |
| K893766 | LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE | Nov 01, 1989 | Substantially Equivalent | Abbott Laboratories |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.