FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
K Number: K033080
·
Decision Mar 10, 2004
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
20
Review Days
163
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
- PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
- K Number
- K033080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Portex, Inc.
- Date Received
- September 29, 2003
- Decision Date
- March 10, 2004
- Product Code
- CAZ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAZ), ordered by most recent decision date.
Arrow 0.2 Micron Flat Filter, GVS
FDA 510(k)
FDA Class 2
·Anesthesiology
BD Epilor Syringe
FDA 510(k)
FDA Class 2
·Anesthesiology
Plastic LOR Syringe
FDA 510(k)
FDA Class 2
·Anesthesiology
E-Cath STIM acc. Tsui
FDA 510(k)
FDA Class 2
·Anesthesiology
VPC
FDA 510(k)
FDA Class 2
·Anesthesiology
Arrow Epidural Catheter Kit
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Portex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031057 | PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT | Jul 18, 2003 | Substantially Equivalent |
| K023793 | 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR | Feb 11, 2003 | Substantially Equivalent |
| K014115 | 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX | Feb 27, 2002 | Substantially Equivalent |
| K014073 | HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE | Feb 13, 2002 | Substantially Equivalent |
| K873992 | LARYNGECTOMY TUBE | Mar 24, 1988 | Substantially Equivalent |
| K874597 | THERMOVENT 600, 1200, T, 02 | Jan 19, 1988 | Substantially Equivalent |
| K862167 | MINI-TRACH KIT | Aug 6, 1986 | Substantially Equivalent |
| K842456 | JET VENTILATION ADAPTOR | Jul 6, 1984 | Substantially Equivalent |
| K833908 | IRRI-CATH | Feb 4, 1984 | Substantially Equivalent |
| K840015 | SWIVEL ADAPTOR W/ALARM PORT | Jan 17, 1984 | Substantially Equivalent |