HEARTPORT ENDOCORONARY SINUS CATHETR
FDA 510(k) clearance K964248 · decided 1997-01-22
Clearance details
- K-number
- K964248
- Device name
- HEARTPORT ENDOCORONARY SINUS CATHETR
- Applicant
- Heartport, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-24
- Decision date
- 1997-01-22
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards Lifes recall (Z-2776-2011) | Edwards Lifesciences, LLC | 2011-07-11 |
| EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile EO, Steri recall (Z-0991-2011) | Edwards Lifesciences Llc | 2011-01-28 |