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FDA 510(k)

SPIRALFUSE PERIPHERAL INFUSION SYSTEM

K-Number: K082199 · 2008-10-17

ApplicantBacchus Vascular, Inc.
Decision Date2008-10-17
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPIRALFUSE PERIPHERAL INFUSION SYSTEM 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 2008-10-17 under 510(k) number K082199. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRALFUSE PERIPHERAL INFUSION SYSTEM?

SPIRALFUSE PERIPHERAL INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-17. The listed applicant is Bacchus Vascular, Inc.. The 510(k) number is K082199.

When did SPIRALFUSE PERIPHERAL INFUSION SYSTEM receive FDA 510(k) clearance?

SPIRALFUSE PERIPHERAL INFUSION SYSTEM received FDA 510(k) clearance on 2008-10-17, under 510(k) number K082199.

Who is the listed applicant for SPIRALFUSE PERIPHERAL INFUSION SYSTEM?

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 SPIRALFUSE PERIPHERAL INFUSION SYSTEM?

The FDA product code for SPIRALFUSE PERIPHERAL INFUSION SYSTEM is QEY.

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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.

K071664TRELLIS-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 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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Related Devices (Code: QEY)

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.

K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc.K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.K220866EKOS+ Endovascular DeviceBoston Scientific

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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