Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)

K-Number: K122937 · 2012-12-14

ApplicantCook, Inc.
Decision Date2012-12-14
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2012-12-14 under 510(k) number K122937. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)?

SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) is a medical device that received FDA 510(k) clearance on 2012-12-14. The listed applicant is Cook, Inc.. The 510(k) number is K122937.

When did SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) receive FDA 510(k) clearance?

SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) received FDA 510(k) clearance on 2012-12-14, under 510(k) number K122937.

Who is the listed applicant for SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)?

The FDA 510(k) record lists Cook, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)?

The FDA product code for SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) is DQO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cook, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K133634SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SETK132020ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETERK131201ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SETK131206COOK CERVICAL RIPENING BALLOONK132334TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SETK122091COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY

View all 184 devices →

Related Devices (Code: DQO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑