[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP
FDA 510(k) clearance K862056 · decided 1986-08-25
Clearance details
- K-number
- K862056
- Device name
- [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-05-30
- Decision date
- 1986-08-25
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
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