510(k) K911382
- Device
- IPI ALGO-LINE CATHETER
- Applicant
- PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
- 510(k) number
- K911382
- Product code
- MAJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-07-18
- Date received
- 1991-03-28
- Regulation
- 868.5120
- Classification name
- Catheter, Percutaneous, Intraspinal, Short Term
- Medical specialty
- Anesthesiology
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- TOM HOLDYCH
- Address
- P.O. Box 2090 Goleta CA US 93118 93118
FDA Registration Numbers#
- 9612501
- 9681477
- 3017636737
- 2011171
- 3015531529
- 3018094310
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MAJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K965251 | MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM | Medtronic Vascular | 1997-03-18 |
| 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 |
| K893766 | LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE | Abbott Laboratories | 1989-11-01 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases