FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IRRI-CATH
K Number: K833908
·
Decision Feb 4, 1984
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
20
Review Days
82
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
- IRRI-CATH
- K Number
- K833908
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Portex, Inc.
- Date Received
- November 14, 1983
- Decision Date
- February 4, 1984
- Product Code
- BSY
- 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSY), ordered by most recent decision date.
MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
AMBU HAND POWER SUCTION PUMP
FDA 510(k)
FDA Class 1
·Anesthesiology
DUAL PURPOSE CLOSED CATHETER
FDA 510(k)
FDA Class 1
·Anesthesiology
SUCTION CATHETER
FDA 510(k)
FDA Class 1
·Anesthesiology
HI-CARE CLOSED SUCTION SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
AMSINO SUCTION CATHETER
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Portex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K033080 | PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER | Mar 10, 2004 | Substantially Equivalent |
| 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 |
| K840015 | SWIVEL ADAPTOR W/ALARM PORT | Jan 17, 1984 | Substantially Equivalent |