FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VESSEL DILATOR AND INTRODUCER SHEATH
K Number: K882238
·
Decision Aug 25, 1988
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
16
Review Days
90
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Basic Information
- Device Name
- VESSEL DILATOR AND INTRODUCER SHEATH
- K Number
- K882238
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Ideal Medical, Inc.
- Date Received
- May 27, 1988
- Decision Date
- August 25, 1988
- Product Code
- DRE
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
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| K914913 | GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST | Dec 31, 1991 | Substantially Equivalent |
| K912540 | CONTOUR-PORT | Aug 23, 1991 | Unknown |