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FDA 510(k)

COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE

K-Number: K101518 · 2010-10-13

ApplicantMirador Biomedical, Inc.
Decision Date2010-10-13
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE is the device name listed in this FDA 510(k) record. The listed applicant is Mirador Biomedical, Inc.. It received FDA 510(k) clearance on 2010-10-13 under 510(k) number K101518. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE?

COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE is a medical device that received FDA 510(k) clearance on 2010-10-13. The listed applicant is Mirador Biomedical, Inc.. The 510(k) number is K101518.

When did COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE receive FDA 510(k) clearance?

COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE received FDA 510(k) clearance on 2010-10-13, under 510(k) number K101518.

Who is the listed applicant for COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE?

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

What is the FDA product code for COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE?

The FDA product code for COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE is DRS.

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Other records listing Mirador Biomedical, 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.

K112203COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSISTK103715COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE

Related Devices (Code: DRS)

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.

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Official Source

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

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