FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTROPEEL V
K Number: K931218
·
Decision Sep 22, 1993
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
31
Review Days
196
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
- INTROPEEL V
- K Number
- K931218
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Menlo Care, Inc.
- Date Received
- March 10, 1993
- Decision Date
- September 22, 1993
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DYB), ordered by most recent decision date.
FieldFlex Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Echo Large Bore Introducer Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Introducer Sheath Set
FDA 510(k)
FDA Class 2
·Cardiovascular
Edwards eSheath+ introducer set
FDA 510(k)
FDA Class 2
·Cardiovascular
Aventus Introducer Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Protaryx Transseptal Puncture Device (PTX2-001)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Menlo Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964447 | PICC CATHETER/MIDLINE CATHETER | Apr 16, 1997 | Substantially Equivalent |
| K951620 | MIDMARK MIDLINE CATHETER | Apr 4, 1996 | Substantially Equivalent |
| K945521 | CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY | Apr 6, 1995 | Substantially Equivalent |
| K944968 | LANDMARK MIDLINE CATHETER | Mar 29, 1995 | Substantially Equivalent |
| K950737 | LANDMARK MIDLINE CATHETER | Mar 29, 1995 | Substantially Equivalent |
| K943893 | PERCUTANEOUS GRAINAGE CATHETER | Mar 7, 1995 | Substantially Equivalent |
| K943143 | BILIARY STENT | Feb 28, 1995 | Substantially Equivalent |
| K930048 | SAFE-PICC CATHETER | May 12, 1994 | Substantially Equivalent |
| K933941 | MENLO CARE URINARY DIVERSION STENT | Mar 31, 1994 | Substantially Equivalent |
| K940127 | CENTERMARK SECURING WINGS | Feb 9, 1994 | Substantially Equivalent |