SINGLE USE SELDINGER/COURNAND PERC. NDL
FDA 510(k) clearance K810859 · decided 1981-04-11
Clearance details
- K-number
- K810859
- Device name
- SINGLE USE SELDINGER/COURNAND PERC. NDL
- Applicant
- Procedure Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-03-30
- Decision date
- 1981-04-11
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- DRE
- Device class
- 2
- Regulation number
- 870.1310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, recall (Z-0355-2016) | Procedure Products, Inc. | 2015-12-01 |