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FDA 510(k)

SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110

K-Number: K033997 · 2004-02-04

ApplicantBacchus Vascular, Inc.
Decision Date2004-02-04
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 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 2004-02-04 under 510(k) number K033997. 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 PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110?

SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 is a medical device that received FDA 510(k) clearance on 2004-02-04. The listed applicant is Bacchus Vascular, Inc.. The 510(k) number is K033997.

When did SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 receive FDA 510(k) clearance?

SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 received FDA 510(k) clearance on 2004-02-04, under 510(k) number K033997.

Who is the listed applicant for SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110?

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 PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110?

The FDA product code for SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 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 SYSTEMK032261Trellis Reserve Infusion SystemK022640SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CMK023514TRELLIS-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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