FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULSE*SPRAY INFUSION SYSTEM
K Number: K961763
·
Decision Jul 17, 1996
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
70
Applicant Total
6
Review Days
71
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Basic Information
- Device Name
- PULSE*SPRAY INFUSION SYSTEM
- K Number
- K961763
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Angiodynamics, Div. E-Z-Em, Inc.
- Date Received
- May 7, 1996
- Decision Date
- July 17, 1996
- Product Code
- QEY
- 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 |
|---|---|---|---|
| QEY | Mechanical Thrombolysis Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Angiodynamics, Div. E-Z-Em, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951509 | PULSE*SPRAY INFUSION SYSTEM | Jun 16, 1995 | Substantially Equivalent |
| K951602 | PULSE*SPRAY INFUSION SYSTEM | Jun 14, 1995 | Substantially Equivalent |
| K950907 | PULSE*SPRAY INFUSION SYSTEM | May 17, 1995 | Substantially Equivalent |
| K933846 | ANGIOGRAPHY SYRINGE KITS | Dec 13, 1994 | Substantially Equivalent |
| K923120 | MICROGUIDE LESION MARKING SYSTEM | Sep 1, 1992 | Substantially Equivalent |