PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E
FDA 510(k) clearance K010538 · decided 2001-03-30
Clearance details
- K-number
- K010538
- Device name
- PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E
- Applicant
- Rd Medical Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-23
- Decision date
- 2001-03-30
- Days to decision
- 35 days
- Clearance type
- Abbreviated
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Cuelbra, PR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.