OBTURATOR
FDA 510(k) clearance K770404 · decided 1977-03-16
Clearance details
- K-number
- K770404
- Device name
- OBTURATOR
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1977-03-03
- Decision date
- 1977-03-16
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- DRB
- Device class
- 2
- Regulation number
- 870.1380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Abbott Park, IL, 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 |
|---|---|---|
| Arrow Stiffening Stylet (K220280) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2022-08-30 |
| Biotronik Stylets (K191469) | Biotronik, Inc. | 2019-08-01 |
| GaltTWS (K182660) | Galt Medical Corp. | 2019-05-30 |
| Liberator Beacon Tip Locking Stylet (K170298) | Cook Incorporated | 2017-10-18 |
| LLD EZ (K142116) | Spectranetics, Inc. | 2014-08-12 |
| STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 (K090163) | St Jude Medical | 2009-04-01 |
| MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 (K080924) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2008-04-30 |
| ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM (K072864) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2008-03-13 |
| ACUITY STEERABLE STYLET ACCESSORY (K053019) | Guidant Corporation | 2006-03-03 |
| EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. (K052965) | Guidant Corporation | 2006-02-13 |
| SPECTRANETICS LLD CS, MODEL 518-039 (K043401) | Spectranetics Corp. | 2005-03-16 |
| STEERABLE STYLET (K040001) | Synovis Surgical Innovations | 2004-03-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |