Atlas FDA

MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210

FDA 510(k) clearance K020765 · decided 2002-04-05

Clearance details

K-number
K020765
Device name
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
2002-03-08
Decision date
2002-04-05
Days to decision
28 days
Clearance type
Traditional
Product code
KTI
Device class
2
Regulation number
874.4680
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Natick,, MA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Boston Scientific Corp

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes (K261274)Cook Ireland, Ltd.2026-07-24
ClearTip TBNA Type (K251478)Finemedix Co., Ltd.2026-04-16
LungFlow Basket Catheter (K254040)Free Flow Medical, Inc.2026-03-12
LIA-1 Catheter (542-1) (K251402)Leadoptik, Inc.2025-12-19
Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 (K252874)Serpex Medical, Inc.2025-10-08
Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) (K251664)Olympus Medical Systems Corporation2025-07-29
Disposable Grasping Forceps FG-52D/FG-54D (K250263)Olympus Medical Systems Corp.2025-03-31
Disposable Cytology Brush (AF series) (K241679)Alton (Shanghai) Medical Instruments Co., Ltd.2025-03-04
METIC™- Airway Balloon Catheter (K231818)M/S Meril Life Sciences Pvt. , Ltd.2023-11-15
EndoCore (K230778)Praxis Medical, LLC2023-09-25
ANDORATE® Suction Valve and ANDORATE® Biopsy Valve (K230280)Ga Health Company Limited2023-05-11
Multistage Balloon Dilatation Catheter (K222187)Dongguan TT Medical, Inc.2023-03-01

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ALTRUA™ 2 (Models S701, S702, S722) ESSENTIO™ (Models L100, L101, L121) PROPONENT™ (Models L200, L201, L221) ACCOLADE™ ( (N970003/S304)Boston Scientific Corp2025-12-19
WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor (P030017/S374)Boston Scientific Corp2025-12-18
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S082)Boston Scientific Corp2025-12-18
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S090)Boston Scientific Corp2025-12-17
ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321) (N970003/S305)Boston Scientific Corp2025-12-17
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S390)Boston Scientific Corp2025-12-17
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S079)Boston Scientific Corp2025-12-15
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S078)Boston Scientific Corp2025-12-15