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FDA 510(k)

SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM

K-Number: K022640 · 2002-12-02

ApplicantBacchus Vascular, Inc.
Decision Date2002-12-02
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM is the device name listed in this FDA 510(k) record. The listed applicant is Bacchus Vascular, Inc.. It received FDA 510(k) clearance on 2002-12-02 under 510(k) number K022640. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM?

SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM is a medical device that received FDA 510(k) clearance on 2002-12-02. The listed applicant is Bacchus Vascular, Inc.. The 510(k) number is K022640.

When did SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM receive FDA 510(k) clearance?

SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM received FDA 510(k) clearance on 2002-12-02, under 510(k) number K022640.

Who is the listed applicant for SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM?

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

What is the FDA product code for SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM?

The FDA product code for SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM is MCW.

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Other records listing Bacchus Vascular, 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.

K082199SPIRALFUSE PERIPHERAL INFUSION SYSTEMK071664TRELLIS-6 PERIPHERAL INFUSION SYSTEMK050147TRELLIS-8 PERIPHERAL INFUSION SYSTEMK033997SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110K032261Trellis Reserve Infusion SystemK023514TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH)

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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.

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