FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
11F GUIDING CATHETER
K Number: K963663
·
Decision Jan 13, 1997
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
5
Review Days
122
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Basic Information
- Device Name
- 11F GUIDING CATHETER
- K Number
- K963663
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific /International Technologies
- Date Received
- September 13, 1996
- Decision Date
- January 13, 1997
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by Boston Scientific /International Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K971688 | IVT 0.014 PTFE-COATED TRACKWIRE | Dec 11, 1997 | Substantially Equivalent |
| K954622 | IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK | Apr 29, 1996 | Substantially Equivalent |
| K954552 | RAILWIRE | Apr 29, 1996 | Substantially Equivalent |
| K930808 | PROTECTOR INTRODUCER SHEATH | Mar 15, 1994 | Substantially Equivalent |