FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REMOTE RESERVOIR ADAPTER CASSETTE W/BAG SPIKE
K Number: K895046
·
Decision Oct 25, 1989
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
43
Review Days
77
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
- REMOTE RESERVOIR ADAPTER CASSETTE W/BAG SPIKE
- K Number
- K895046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Pharmacia Deltec, Inc.
- Date Received
- August 9, 1989
- Decision Date
- October 25, 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 Pharmacia Deltec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943310 | MODEL 6100 AMBULATORY INFUSION SYSTEM | Feb 21, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K942046 | PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE | Oct 4, 1994 | Substantially Equivalent |
| K942161 | LOCKBOX | Aug 2, 1994 | Substantially Equivalent - Subject to Tracking Reg. |
| K942024 | PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM | Jul 26, 1994 | Substantially Equivalent |
| K941445 | EXTENSION SET WITH ANTI-SIPHON VALVE | Jun 29, 1994 | Substantially Equivalent |
| K931073 | CATH-FINDER | May 5, 1994 | Substantially Equivalent |
| K932430 | DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER | May 2, 1994 | Unknown |
| K932433 | PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE | May 2, 1994 | Unknown |
| K932198 | PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH | May 2, 1994 | Unknown |
| K932464 | PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH. | May 2, 1994 | Unknown |