Atlas FDA

Biotronik Stylets

FDA 510(k) clearance K191469 · decided 2019-08-01

Clearance details

K-number
K191469
Device name
Biotronik Stylets
Applicant
Biotronik, Inc.
Decision
Substantially Equivalent
Date received
2019-06-03
Decision date
2019-08-01
Days to decision
59 days
Clearance type
Traditional
Product code
DRB
Device class
2
Regulation number
870.1380
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Lake Oswego, OR, 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.

RecordFirmDate
Arrow Stiffening Stylet (K220280)Arrow International, LLC (A subsidiary of Teleflex, Inc.)2022-08-30
GaltTWS (K182660)Galt Medical Corp.2019-05-30
Liberator Beacon Tip Locking Stylet (K170298)Cook Incorporated2017-10-18
LLD EZ (K142116)Spectranetics, Inc.2014-08-12
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 (K090163)St Jude Medical2009-04-01
MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 (K080924)St. Jude Medical, Cardiac Rhythm Management Divisi2008-04-30
ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM (K072864)St. Jude Medical, Cardiac Rhythm Management Divisi2008-03-13
ACUITY STEERABLE STYLET ACCESSORY (K053019)Guidant Corporation2006-03-03
EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. (K052965)Guidant Corporation2006-02-13
SPECTRANETICS LLD CS, MODEL 518-039 (K043401)Spectranetics Corp.2005-03-16
STEERABLE STYLET (K040001)Synovis Surgical Innovations2004-03-09
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 (K010906)Medtronic Vascular2001-04-05

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Acticor Sky DR-T 481987, Rivacor Sky DR-T 481982, Rivacor Rise DR-T 482018, Rivacor Aura DR-T 482014 (P000009/S120)Biotronik, Inc.2025-12-18
Acticor Sky VR-T 481989, Rivacor Sky VR-T 481984, Rivacor Rise VR-T 482020, Rivacor Aura VR-T 482015, Acticor Sky VR-T D (P980023/S136)Biotronik, Inc.2025-12-18
Solia S 53 377177; Solia S 60 377179 (P950037/S274)Biotronik, Inc.2025-12-18
Acticor Sky HF-T 481986, Rivacor Sky HF-T 481991, Rivacor Rise HF-T 482017, Rivacor Aura HF-T 482013, Acticor Sky HF-T Q (P050023/S199)Biotronik, Inc.2025-12-18
Sentus ProMRI OTW QP S-75; Sentus ProMRI OTW QP S-85; Sentus ProMRI OTW QP S-95; Sentus ProMRI OTW QP L-75; Sentus ProMR (P070008/S173)Biotronik, Inc.2025-12-10
Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53; Siello S 45; Sie (P950037/S281)Biotronik, Inc.2025-12-10
Pamira S 60 428768 Pamira S 65 428769 Pamira S 75 428770 Pamira SD 60/16 428771 Pamira SD 65/16 428772 Pamira SD 65/18 4 (P980023/S141)Biotronik, Inc.2025-10-29
Acticor 7 VR-T; Rivacor 7 VR-T; Rivacor 5 VR-T; Rivacor 3 VR-T; Acticor 7 VR-T DX; Rivacor 7 VR-T DX; Rivacor 5 VR-T DX; (P050023/S196)Biotronik, Inc.2025-10-24