SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
FDA 510(k) clearance K220981 · decided 2023-04-20
Clearance details
- K-number
- K220981
- Device name
- SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
- Applicant
- Fehling Surgical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-04-04
- Decision date
- 2023-04-20
- Days to decision
- 381 days
- Clearance type
- Traditional
- Product code
- DWP
- Device class
- 2
- Regulation number
- 870.4475
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Kennesaw, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Geomed Vascular Dilators (K183438) | Geomed Medizin-Technik GmbH & Co. | 2019-09-03 |
| Vessel Dilator (K163524) | Fetzer Medical GmbH & Co. KG | 2017-06-29 |
| VASCULAR PROBE, VASCULAR PROBE ES (K130896) | Synovis Life Technologies, Inc. | 2013-04-24 |
| INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 (K100518) | Instrumed International, Inc. | 2010-08-31 |
| KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS (K030788) | Geister Medizin Technik GmbH | 2003-07-12 |
| RDI CARDIAC INSULATION PAD (K960312) | R D Intl. | 1996-04-19 |
| LEMAITRE-BOOKWALTER VESSEL DEVICES (K912548) | Vascutech, Inc. | 1991-09-18 |
| LAPAROSCOPIC VESSEL ARTICULATOR (K911475) | United States Endoscopy Group, Inc. | 1991-07-02 |
| ROBICSEK PROBE/RETRACTOR (K910682) | Bio-Vascular, Inc. | 1991-05-08 |
| FLO-RESTER(R) VESSEL SIZER (K905159) | Bio-Vascular, Inc. | 1991-02-07 |
| FOGARTY VESSEL CALIBRATOR (K902143) | Baxter Healthcare Corp | 1990-10-16 |
| PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) (K891786) | Pioneering Technologies, Inc. | 1989-10-12 |
Recalls involving this device
No recalls on record reference this clearance.