FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED PEEL-AWAY INTRODUCER SET LINE
K Number: K864352
·
Decision Jan 6, 1987
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
164
Review Days
63
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Basic Information
- Device Name
- MODIFIED PEEL-AWAY INTRODUCER SET LINE
- K Number
- K864352
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Quinton, Inc.
- Date Received
- November 4, 1986
- Decision Date
- January 6, 1987
- 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 |
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|---|---|---|---|
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| K971397 | VIEWCATH 3-D CATHETER PULLBACK | Aug 25, 1997 | Substantially Equivalent |
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| K964978 | VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) | May 21, 1997 | Substantially Equivalent |
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