FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLUNT NEEDLE PORT/I.V. PORT
K Number: K895480
·
Decision Dec 1, 1989
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
23
Review Days
81
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
- BLUNT NEEDLE PORT/I.V. PORT
- K Number
- K895480
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Applied Medical Technologies
- Date Received
- September 11, 1989
- Decision Date
- December 1, 1989
- 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 Applied Medical Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K971434 | A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE | Aug 17, 1998 | Substantially Equivalent |
| K972478 | PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES | Feb 9, 1998 | Substantially Equivalent |
| K973893 | AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE | Dec 19, 1997 | Substantially Equivalent |
| K971757 | LOW PROFILE FEEDING SET ACCESSORY | Nov 7, 1997 | Substantially Equivalent |
| K971758 | CAUTERIZATION SMOKE EVACUATOR | Jul 21, 1997 | Substantially Equivalent |
| K961345 | DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE | Sep 17, 1996 | Substantially Equivalent |
| K960232 | ENDOSCOPIC ACCESS DEVICE | Mar 21, 1996 | Substantially Equivalent |
| K945618 | GASTROINTESTINAL TUBES & ACCESSORIES | Oct 12, 1995 | Substantially Equivalent |
| K946140 | PRG BUTTON | Aug 28, 1995 | Substantially Equivalent |
| K923488 | GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY | Jul 20, 1995 | Substantially Equivalent |