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FDA 510(k)

ASTRONOMER+WITH SLD

K-Number: K003362 · 2001-03-01

ApplicantBoston Scientific Corp
Decision Date2001-03-01
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASTRONOMER+WITH SLD is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2001-03-01 under 510(k) number K003362. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASTRONOMER+WITH SLD?

ASTRONOMER+WITH SLD is a medical device that received FDA 510(k) clearance on 2001-03-01. The listed applicant is Boston Scientific Corp. The 510(k) number is K003362.

When did ASTRONOMER+WITH SLD receive FDA 510(k) clearance?

ASTRONOMER+WITH SLD received FDA 510(k) clearance on 2001-03-01, under 510(k) number K003362.

Who is the listed applicant for ASTRONOMER+WITH SLD?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASTRONOMER+WITH SLD?

The FDA product code for ASTRONOMER+WITH SLD is DQK.

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Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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