FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
V-CATH BREAKAWAY NEEDLE INTRODUCER
K Number: K945473
·
Decision Jan 20, 1995
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
46
Applicant Total
30
Review Days
73
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
- V-CATH BREAKAWAY NEEDLE INTRODUCER
- K Number
- K945473
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6920
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hdc Corp.
- Date Received
- November 8, 1994
- Decision Date
- January 20, 1995
- Product Code
- KZH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KZH | Introducer, Syringe Needle | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KZH), ordered by most recent decision date.
GripMate
FDA 510(k)
FDA Class 2
·General Hospital
AccuSert Needle Inserter
FDA 510(k)
FDA Class 2
·General Hospital
Orbit Inserter
FDA 510(k)
FDA Class 2
·General Hospital
MiniMed Quick-serter
FDA 510(k)
FDA Class 2
·General Hospital
WHISPERJECT AUTOINJECTOR
FDA 510(k)
FDA Class 2
·General Hospital
LOBSTER AUTO-INJECTOR
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Hdc Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K071875 | V-CATH POLY PICC | Nov 5, 2007 | Substantially Equivalent |
| K023342 | NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG | Mar 2, 2004 | Substantially Equivalent |
| K033853 | MODIFICATION TO V-CATH POLY PICC | Jan 14, 2004 | Substantially Equivalent |
| K032404 | SELDINGER SAFETY NEEDLE INTRODUCER | Sep 10, 2003 | Substantially Equivalent |
| K022752 | PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15 | Sep 9, 2003 | Substantially Equivalent |
| K022099 | SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S | Sep 20, 2002 | Substantially Equivalent |
| K010425 | EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) | Mar 15, 2001 | Substantially Equivalent |
| K994059 | CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07 | Oct 13, 2000 | Substantially Equivalent |
| K002770 | IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10 | Sep 26, 2000 | Substantially Equivalent |
| K983119 | ENTERO-TEST HP, MODEL #102-01 | Mar 15, 1999 | Substantially Equivalent |