FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENTRI-CATH
K Number: K931989
·
Decision Jul 21, 1993
Classifications
1
FEI Numbers
68
Registration Numbers
69
Same Product Code
257
Applicant Total
26
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VENTRI-CATH
- K Number
- K931989
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gesco Intl., Inc.
- Date Received
- April 22, 1993
- Decision Date
- July 21, 1993
- Product Code
- JXG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JXG), ordered by most recent decision date.
Intellidrop
FDA 510(k)
FDA Class 2
·Neurology
Sophy Mini Monopressure Valve (SM1)
FDA 510(k)
FDA Class 2
·Neurology
EVAC-MRI
FDA 510(k)
FDA Class 2
·Neurology
Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology
FDA 510(k)
FDA Class 2
·Neurology
Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)
FDA 510(k)
FDA Class 2
·Neurology
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Gesco Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954422 | PER-Q-CATH MID-LINE | Dec 15, 1995 | Substantially Equivalent |
| K940953 | UMBILI-CATH-S | Aug 2, 1994 | Substantially Equivalent |
| K940870 | UMBILI-CATH | Aug 2, 1994 | Substantially Equivalent |
| K940952 | UMBILI-CATH-S-DL | Jul 29, 1994 | Substantially Equivalent |
| K941672 | URI-CATH CATHETER | May 16, 1994 | Substantially Equivalent |
| K941232 | THORA-CATH | May 11, 1994 | Substantially Equivalent |
| K940871 | UMBILI-CATH-P | Apr 29, 1994 | Substantially Equivalent |
| K926063 | PER-Q-CATH DRESSING CHANGE TRAY | Jun 7, 1993 | Unknown |
| K923591 | PALA-NATE | Mar 16, 1993 | Substantially Equivalent |
| K915167 | GESCO PER-Q-CATH CATHETER INTRODUCER | Jan 27, 1992 | Substantially Equivalent |