FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DURHAM; MIN BORE LUER LOCK EXTENSION SET
K Number: K930406
·
Decision Sep 3, 1993
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
17
Review Days
220
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
- DURHAM; MIN BORE LUER LOCK EXTENSION SET
- K Number
- K930406
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Intl. Medical, Inc.
- Date Received
- January 26, 1993
- Decision Date
- September 3, 1993
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPA), ordered by most recent decision date.
iiSure Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
FDA 510(k)
FDA Class 2
·General Hospital
PuraCath Firefly Needleless Connector IT (9005)
FDA 510(k)
FDA Class 2
·General Hospital
nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
FDA 510(k)
FDA Class 2
·General Hospital
BD Alaris Pump Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
EZ IV Administration Set
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Intl. Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970507 | PEAK FLOW METER | Jun 13, 1997 | Substantially Equivalent |
| K943078 | HOT BIOPSY FORCEPS | Nov 14, 1994 | Substantially Equivalent |
| K940370 | AMERICAN CATHETER E.R.C.P. CANNULA | Aug 17, 1994 | Substantially Equivalent |
| K940335 | AMERICAN CATHETER POLY-SNARE | Jul 21, 1994 | Substantially Equivalent |
| K942068 | AMERICAN CATHETER SPHINCTEROTOME | Jun 24, 1994 | Substantially Equivalent |
| K930410 | DURHAM; LUER LOCK EXTENSION SET | Sep 3, 1993 | Substantially Equivalent |
| K923200 | AMCATH DISPOSABLE CYTOLOGY BRUSH | Dec 7, 1992 | Substantially Equivalent |
| K915142 | AMCATH DISPOSABLE BIOPSY FORCEPS | Jan 10, 1992 | Substantially Equivalent |
| K912927 | AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE | Sep 19, 1991 | Substantially Equivalent |
| K912605 | AMCATH DISPOSABLE MICRO SCISSORS | Jul 11, 1991 | Substantially Equivalent |