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FDA 510(k)

SWABCAP AND SWABFLUSH

K-Number: K130975 · 2013-12-24

ApplicantExcelsior Medical Corp.
Decision Date2013-12-24
Product CodeQBP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SWABCAP AND SWABFLUSH is the device name listed in this FDA 510(k) record. The listed applicant is Excelsior Medical Corp.. It received FDA 510(k) clearance on 2013-12-24 under 510(k) number K130975. The device is classified under product code QBP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWABCAP AND SWABFLUSH?

SWABCAP AND SWABFLUSH is a medical device that received FDA 510(k) clearance on 2013-12-24. The listed applicant is Excelsior Medical Corp.. The 510(k) number is K130975.

When did SWABCAP AND SWABFLUSH receive FDA 510(k) clearance?

SWABCAP AND SWABFLUSH received FDA 510(k) clearance on 2013-12-24, under 510(k) number K130975.

Who is the listed applicant for SWABCAP AND SWABFLUSH?

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

What is the FDA product code for SWABCAP AND SWABFLUSH?

The FDA product code for SWABCAP AND SWABFLUSH is QBP.

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Other records listing Excelsior Medical Corp. 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.

K101270SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311K083508SWABCAPK082837STERILE FIELD SALINE PRE-FILLED SYRINGE(S)K061497SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/MLK053120STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGESK023740SYREX PRE-FILLED SYRINGE

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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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