FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHEATH/DILATORS
K Number: K872724
·
Decision Sep 15, 1987
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
11
Review Days
69
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
- SHEATH/DILATORS
- K Number
- K872724
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Med-West, Inc.
- Date Received
- July 8, 1987
- Decision Date
- September 15, 1987
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRE), ordered by most recent decision date.
ProtekDilate Vascular Access Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
VersaCross Connect Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
Micro Ace Gold Advanced Micro Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
VersaCross Connect Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
VersaCross Connect Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
Micro Ace Advanced Micro Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Med-West, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880877 | CONTRAST INJECTION DEVICE | May 31, 1988 | Substantially Equivalent |
| K880398 | POWER TOILET ELEVATOR | Mar 17, 1988 | Substantially Equivalent |
| K874470 | MWI 400 WOUND DRESSING | Dec 18, 1987 | Substantially Equivalent for Some Indications |
| K854612 | ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 | Jan 3, 1986 | Unknown |
| K852162 | MNI 400 INJECTION CAPS | Jun 12, 1985 | Substantially Equivalent |
| K842342 | MWI 888 & 666 DOUBLE LUMEN SUBCLAVIAN | Jun 14, 1984 | Unknown |
| K832124 | CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI | Aug 12, 1983 | Substantially Equivalent |
| K831828 | TEFLON FEMORAL CATHETER MWI 100,10 & | Jul 7, 1983 | Substantially Equivalent |
| K831401 | SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS | Jun 3, 1983 | Substantially Equivalent |
| K831440 | SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 | Jun 3, 1983 | Substantially Equivalent |