FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTRAST INJECTION DEVICE
K Number: K880877
·
Decision May 31, 1988
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
209
Applicant Total
11
Review Days
91
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Basic Information
- Device Name
- CONTRAST INJECTION DEVICE
- K Number
- K880877
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Med-West, Inc.
- Date Received
- March 1, 1988
- Decision Date
- May 31, 1988
- Product Code
- DXT
- 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 |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | FDA class 2 | Cardiovascular |
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Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr
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Other Clearances by Med-West, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880398 | POWER TOILET ELEVATOR | Mar 17, 1988 | Substantially Equivalent |
| K874470 | MWI 400 WOUND DRESSING | Dec 18, 1987 | Substantially Equivalent for Some Indications |
| K872724 | SHEATH/DILATORS | Sep 15, 1987 | Substantially Equivalent |
| 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 |