FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANGIOMED HIGH PRESSURE CONNECTORS
K Number: K863446
·
Decision Sep 23, 1986
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
7
Applicant Total
24
Review Days
15
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
- ANGIOMED HIGH PRESSURE CONNECTORS
- K Number
- K863446
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Angiomed U.S., Inc.
- Date Received
- September 8, 1986
- Decision Date
- September 23, 1986
- Product Code
- GCD
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCD | Connector, Catheter | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCD), ordered by most recent decision date.
ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
L-CATH CONNECTOR ASSEMBLY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INCISION DRAIN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Y CONNECTOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CATHETER CONNECTOR, ARGYLE TUBING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CONNECTORS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Angiomed U.S., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874771 | ANGIOMED INTRODUCING SETS | Jan 12, 1988 | Substantially Equivalent |
| K874585 | ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE | Dec 2, 1987 | Substantially Equivalent |
| K864225 | ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT | Jan 30, 1987 | Substantially Equivalent |
| K863386 | VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS | Oct 24, 1986 | Substantially Equivalent |
| K862805 | ANGIOMED VAC-U-CUT BIOPSY NEEDLE | Sep 29, 1986 | Substantially Equivalent |
| K854910 | ANGIOFLOW | Jul 17, 1986 | Substantially Equivalent |
| K854912 | ANGIOMED GUIED WIRES | Apr 16, 1986 | Substantially Equivalent |
| K854908 | UROFLEX | Mar 14, 1986 | Substantially Equivalent |
| K855142 | ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY | Mar 11, 1986 | Substantially Equivalent |
| K855076 | ANGIOMED URETER DIATION SETS | Mar 11, 1986 | Substantially Equivalent |